This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4
Orders and Observations Work Group | Maturity Level: 1 | Trial Use | Security Category: Anonymous | Compartments: Not linked to any defined compartments |
The characteristics, operational status and capabilities of a medical-related component of a medical device.
The DeviceDefinition resource is used to describe the characteristics and capabilities of a medical device. It also includes packaging information; For kits that can be assembled and repackaged, the packaging is defined at the kit level, but the custom repackaging of that kit is not covered.
The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the regulatory entities, or it is a local definition that includes assembled device configurations. The DeviceDefinition allows defining hierarchical device configurations (devices as part of other devices).
Device vs deviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location, which the DeviceDefinition resource does not have.
This resource is referenced by AdministrableProductDefinition, CatalogEntry, ClinicalUseIssue, Device, itself, ObservationDefinition and RegulatedAuthorization.
This resource does not implement any patterns.
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | TU | DomainResource | An instance of a medical-related component of a medical device Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | 0..* | Identifier | Instance identifier | |
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | |
deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | |
issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
manufacturer[x] | 0..1 | Name of device manufacturer | ||
manufacturerString | string | |||
manufacturerReference | Reference(Organization) | |||
deviceName | 0..* | BackboneElement | The name or names of the device as given by the manufacturer | |
name | 1..1 | string | A name that is used to refer to the device | |
type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DeviceNameType (Required) | |
modelNumber | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer | |
type | 0..* | CodeableConcept | What kind of device or device system this is Device Type (Example) | |
specialization | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |
systemType | 1..1 | string | The standard that is used to operate and communicate | |
version | 0..1 | string | The version of the standard that is used to operate and communicate | |
hasPart | 0..* | BackboneElement | A device, part of the current one | |
reference | 1..1 | Reference(DeviceDefinition) | Reference to the part | |
count | 0..1 | integer | Number of occurrences of the part | |
packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | |
identifier | 0..1 | Identifier | Business identifier of the packaged medication | |
type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
count | 0..1 | integer | The number of items contained in the package (devices or sub-packages) | |
distributor | 0..* | BackboneElement | An organization that distributes the packaged device | |
name | 0..1 | string | Distributor's human-readable name | |
organizationReference | 0..* | Reference() | Distributor as an Organization resource | |
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging | |
deviceIdentifier | 1..1 | string | Identifier to be associated with every instance for issuer and jurisdiction | |
issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
packaging | 0..* | see packaging | Allows packages within packages | |
version | 0..* | BackboneElement | The version of the device or software | |
type | 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | |
component | 0..1 | Identifier | The hardware or software module of the device to which the version applies | |
value | 1..1 | string | The version text | |
safety | Σ | 0..* | CodeableConcept | Safety characteristics of the device Safety (Example) |
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
physicalCharacteristics | 0..1 | ProdCharacteristic | Physical characteristics to define or specify the product - for example dimensions, color etc. | |
languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |
capability | 0..* | BackboneElement | Additional capabilities of the device | |
type | 1..1 | CodeableConcept | The type of capability - whether it is a physical attribute, a customization needed | |
description | 0..* | CodeableConcept | The actual capability of the device | |
property | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |
type | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |
valueQuantity | 0..* | Quantity | Property value as a quantity | |
valueCode | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |
owner | 0..1 | Reference(Organization) | Organization responsible for device | |
contact | 0..* | ContactPoint | Details for human/organization for support | |
onlineInformation | 0..1 | uri | Access to on-line information | |
note | 0..* | Annotation | Device notes and comments | |
parentDevice | Σ | 0..1 | Reference(DeviceDefinition) | The parent device it can be part of |
material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | |
substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | |
alternate | 0..1 | boolean | Indicates an alternative material of the device | |
allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen | |
Documentation for this format |
UML Diagram (Legend)
XML Template
<DeviceDefinition xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Instance identifier --></identifier> <udiDeviceIdentifier> <!-- 0..* Unique Device Identifier (UDI) Barcode string --> <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier --> <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm --> <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies --> </udiDeviceIdentifier> <manufacturer[x]><!-- 0..1 string|Reference(Organization) Name of device manufacturer --></manufacturer[x]> <deviceName> <!-- 0..* The name or names of the device as given by the manufacturer --> <name value="[string]"/><!-- 1..1 A name that is used to refer to the device --> <type value="[code]"/><!-- 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other --> </deviceName> <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer --> <type><!-- 0..* CodeableConcept What kind of device or device system this is --></type> <specialization> <!-- 0..* The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication --> <systemType value="[string]"/><!-- 1..1 The standard that is used to operate and communicate --> <version value="[string]"/><!-- 0..1 The version of the standard that is used to operate and communicate --> </specialization> <hasPart> <!-- 0..* A device, part of the current one --> <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference> <count value="[integer]"/><!-- 0..1 Number of occurrences of the part --> </hasPart> <packaging> <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged --> <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier> <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type> <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) --> <distributor> <!-- 0..* An organization that distributes the packaged device --> <name value="[string]"/><!-- 0..1 Distributor's human-readable name --> <organizationReference><!-- 0..* Reference Distributor as an Organization resource --></organizationReference> </distributor> <udiDeviceIdentifier> <!-- 0..* Unique Device Identifier (UDI) Barcode string on the packaging --> <deviceIdentifier value="[string]"/><!-- 1..1 Identifier to be associated with every instance for issuer and jurisdiction --> <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm --> <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies --> </udiDeviceIdentifier> <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging> </packaging> <version> <!-- 0..* The version of the device or software --> <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </version> <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <physicalCharacteristics><!-- 0..1 ProdCharacteristic Physical characteristics to define or specify the product - for example dimensions, color etc. --></physicalCharacteristics> <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode> <capability> <!-- 0..* Additional capabilities of the device --> <type><!-- 1..1 CodeableConcept The type of capability - whether it is a physical attribute, a customization needed --></type> <description><!-- 0..* CodeableConcept The actual capability of the device --></description> </capability> <property> <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties --> <type><!-- 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible) --></type> <valueQuantity><!-- 0..* Quantity Property value as a quantity --></valueQuantity> <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode> </property> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <onlineInformation value="[uri]"/><!-- 0..1 Access to on-line information --> <note><!-- 0..* Annotation Device notes and comments --></note> <parentDevice><!-- 0..1 Reference(DeviceDefinition) The parent device it can be part of --></parentDevice> <material> <!-- 0..* A substance used to create the material(s) of which the device is made --> <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance> <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device --> <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen --> </material> </DeviceDefinition>
JSON Template
{ "resourceType" : "DeviceDefinition", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // Instance identifier "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string "deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier "issuer" : "<uri>", // R! The organization that assigns the identifier algorithm "jurisdiction" : "<uri>" // R! The jurisdiction to which the deviceIdentifier applies }], // manufacturer[x]: Name of device manufacturer. One of these 2: "manufacturerString" : "<string>", "manufacturerReference" : { Reference(Organization) }, "deviceName" : [{ // The name or names of the device as given by the manufacturer "name" : "<string>", // R! A name that is used to refer to the device "type" : "<code>" // R! udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other }], "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer "type" : [{ CodeableConcept }], // What kind of device or device system this is "specialization" : [{ // The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication "systemType" : "<string>", // R! The standard that is used to operate and communicate "version" : "<string>" // The version of the standard that is used to operate and communicate }], "hasPart" : [{ // A device, part of the current one "reference" : { Reference(DeviceDefinition) }, // R! Reference to the part "count" : <integer> // Number of occurrences of the part }], "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged "identifier" : { Identifier }, // Business identifier of the packaged medication "type" : { CodeableConcept }, // A code that defines the specific type of packaging "count" : <integer>, // The number of items contained in the package (devices or sub-packages) "distributor" : [{ // An organization that distributes the packaged device "name" : "<string>", // Distributor's human-readable name "organizationReference" : [{ Reference }] // Distributor as an Organization resource }], "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string on the packaging "deviceIdentifier" : "<string>", // R! Identifier to be associated with every instance for issuer and jurisdiction "issuer" : "<uri>", // R! The organization that assigns the identifier algorithm "jurisdiction" : "<uri>" // R! The jurisdiction to which the deviceIdentifier applies }], "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages }], "version" : [{ // The version of the device or software "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal "component" : { Identifier }, // The hardware or software module of the device to which the version applies "value" : "<string>" // R! The version text }], "safety" : [{ CodeableConcept }], // Safety characteristics of the device "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information "physicalCharacteristics" : { ProdCharacteristic }, // Physical characteristics to define or specify the product - for example dimensions, color etc. "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported) "capability" : [{ // Additional capabilities of the device "type" : { CodeableConcept }, // R! The type of capability - whether it is a physical attribute, a customization needed "description" : [{ CodeableConcept }] // The actual capability of the device }], "property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties "type" : { CodeableConcept }, // R! Code that specifies the property DeviceDefinitionPropetyCode (Extensible) "valueQuantity" : [{ Quantity }], // Property value as a quantity "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP) }], "owner" : { Reference(Organization) }, // Organization responsible for device "contact" : [{ ContactPoint }], // Details for human/organization for support "onlineInformation" : "<uri>", // Access to on-line information "note" : [{ Annotation }], // Device notes and comments "parentDevice" : { Reference(DeviceDefinition) }, // The parent device it can be part of "material" : [{ // A substance used to create the material(s) of which the device is made "substance" : { CodeableConcept }, // R! A relevant substance that the device contains, may contain, or is made of "alternate" : <boolean>, // Indicates an alternative material of the device "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen }] }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:DeviceDefinition; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:DeviceDefinition.identifier [ Identifier ], ... ; # 0..* Instance identifier fhir:DeviceDefinition.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string fhir:DeviceDefinition.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier fhir:DeviceDefinition.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm fhir:DeviceDefinition.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies ], ...; # DeviceDefinition.manufacturer[x] : 0..1 Name of device manufacturer. One of these 2 fhir:DeviceDefinition.manufacturerString [ string ] fhir:DeviceDefinition.manufacturerReference [ Reference(Organization) ] fhir:DeviceDefinition.deviceName [ # 0..* The name or names of the device as given by the manufacturer fhir:DeviceDefinition.deviceName.name [ string ]; # 1..1 A name that is used to refer to the device fhir:DeviceDefinition.deviceName.type [ code ]; # 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other ], ...; fhir:DeviceDefinition.modelNumber [ string ]; # 0..1 The catalog or model number for the device for example as defined by the manufacturer fhir:DeviceDefinition.type [ CodeableConcept ], ... ; # 0..* What kind of device or device system this is fhir:DeviceDefinition.specialization [ # 0..* The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication fhir:DeviceDefinition.specialization.systemType [ string ]; # 1..1 The standard that is used to operate and communicate fhir:DeviceDefinition.specialization.version [ string ]; # 0..1 The version of the standard that is used to operate and communicate ], ...; fhir:DeviceDefinition.hasPart [ # 0..* A device, part of the current one fhir:DeviceDefinition.hasPart.reference [ Reference(DeviceDefinition) ]; # 1..1 Reference to the part fhir:DeviceDefinition.hasPart.count [ integer ]; # 0..1 Number of occurrences of the part ], ...; fhir:DeviceDefinition.packaging [ # 0..* Information about the packaging of the device, i.e. how the device is packaged fhir:DeviceDefinition.packaging.identifier [ Identifier ]; # 0..1 Business identifier of the packaged medication fhir:DeviceDefinition.packaging.type [ CodeableConcept ]; # 0..1 A code that defines the specific type of packaging fhir:DeviceDefinition.packaging.count [ integer ]; # 0..1 The number of items contained in the package (devices or sub-packages) fhir:DeviceDefinition.packaging.distributor [ # 0..* An organization that distributes the packaged device fhir:DeviceDefinition.packaging.distributor.name [ string ]; # 0..1 Distributor's human-readable name fhir:DeviceDefinition.packaging.distributor.organizationReference [ Reference ], ... ; # 0..* Distributor as an Organization resource ], ...; fhir:DeviceDefinition.packaging.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string on the packaging fhir:DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 Identifier to be associated with every instance for issuer and jurisdiction fhir:DeviceDefinition.packaging.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm fhir:DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies ], ...; fhir:DeviceDefinition.packaging.packaging [ See DeviceDefinition.packaging ], ... ; # 0..* Allows packages within packages ], ...; fhir:DeviceDefinition.version [ # 0..* The version of the device or software fhir:DeviceDefinition.version.type [ CodeableConcept ]; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:DeviceDefinition.version.component [ Identifier ]; # 0..1 The hardware or software module of the device to which the version applies fhir:DeviceDefinition.version.value [ string ]; # 1..1 The version text ], ...; fhir:DeviceDefinition.safety [ CodeableConcept ], ... ; # 0..* Safety characteristics of the device fhir:DeviceDefinition.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information fhir:DeviceDefinition.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Physical characteristics to define or specify the product - for example dimensions, color etc. fhir:DeviceDefinition.languageCode [ CodeableConcept ], ... ; # 0..* Language code for the human-readable text strings produced by the device (all supported) fhir:DeviceDefinition.capability [ # 0..* Additional capabilities of the device fhir:DeviceDefinition.capability.type [ CodeableConcept ]; # 1..1 The type of capability - whether it is a physical attribute, a customization needed fhir:DeviceDefinition.capability.description [ CodeableConcept ], ... ; # 0..* The actual capability of the device ], ...; fhir:DeviceDefinition.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties fhir:DeviceDefinition.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property DeviceDefinitionPropetyCode (Extensible) fhir:DeviceDefinition.property.valueQuantity [ Quantity ], ... ; # 0..* Property value as a quantity fhir:DeviceDefinition.property.valueCode [ CodeableConcept ], ... ; # 0..* Property value as a code, e.g., NTP4 (synced to NTP) ], ...; fhir:DeviceDefinition.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device fhir:DeviceDefinition.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support fhir:DeviceDefinition.onlineInformation [ uri ]; # 0..1 Access to on-line information fhir:DeviceDefinition.note [ Annotation ], ... ; # 0..* Device notes and comments fhir:DeviceDefinition.parentDevice [ Reference(DeviceDefinition) ]; # 0..1 The parent device it can be part of fhir:DeviceDefinition.material [ # 0..* A substance used to create the material(s) of which the device is made fhir:DeviceDefinition.material.substance [ CodeableConcept ]; # 1..1 A relevant substance that the device contains, may contain, or is made of fhir:DeviceDefinition.material.alternate [ boolean ]; # 0..1 Indicates an alternative material of the device fhir:DeviceDefinition.material.allergenicIndicator [ boolean ]; # 0..1 Whether the substance is a known or suspected allergen ], ...; ]
Changes since R3
DeviceDefinition | |
DeviceDefinition.deviceName.type |
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DeviceDefinition.type |
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DeviceDefinition.hasPart |
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DeviceDefinition.hasPart.reference |
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DeviceDefinition.hasPart.count |
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DeviceDefinition.packaging |
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DeviceDefinition.packaging.identifier |
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DeviceDefinition.packaging.type |
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DeviceDefinition.packaging.count |
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DeviceDefinition.packaging.distributor |
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DeviceDefinition.packaging.distributor.name |
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DeviceDefinition.packaging.distributor.organizationReference |
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DeviceDefinition.packaging.udiDeviceIdentifier |
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DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier |
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DeviceDefinition.packaging.udiDeviceIdentifier.issuer |
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DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction |
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DeviceDefinition.packaging.packaging |
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DeviceDefinition.version |
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DeviceDefinition.version.type |
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DeviceDefinition.version.component |
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DeviceDefinition.version.value |
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DeviceDefinition.url |
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DeviceDefinition.quantity |
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See the Full Difference for further information
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | TU | DomainResource | An instance of a medical-related component of a medical device Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | 0..* | Identifier | Instance identifier | |
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | |
deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | |
issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
manufacturer[x] | 0..1 | Name of device manufacturer | ||
manufacturerString | string | |||
manufacturerReference | Reference(Organization) | |||
deviceName | 0..* | BackboneElement | The name or names of the device as given by the manufacturer | |
name | 1..1 | string | A name that is used to refer to the device | |
type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DeviceNameType (Required) | |
modelNumber | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer | |
type | 0..* | CodeableConcept | What kind of device or device system this is Device Type (Example) | |
specialization | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |
systemType | 1..1 | string | The standard that is used to operate and communicate | |
version | 0..1 | string | The version of the standard that is used to operate and communicate | |
hasPart | 0..* | BackboneElement | A device, part of the current one | |
reference | 1..1 | Reference(DeviceDefinition) | Reference to the part | |
count | 0..1 | integer | Number of occurrences of the part | |
packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | |
identifier | 0..1 | Identifier | Business identifier of the packaged medication | |
type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
count | 0..1 | integer | The number of items contained in the package (devices or sub-packages) | |
distributor | 0..* | BackboneElement | An organization that distributes the packaged device | |
name | 0..1 | string | Distributor's human-readable name | |
organizationReference | 0..* | Reference() | Distributor as an Organization resource | |
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging | |
deviceIdentifier | 1..1 | string | Identifier to be associated with every instance for issuer and jurisdiction | |
issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
packaging | 0..* | see packaging | Allows packages within packages | |
version | 0..* | BackboneElement | The version of the device or software | |
type | 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | |
component | 0..1 | Identifier | The hardware or software module of the device to which the version applies | |
value | 1..1 | string | The version text | |
safety | Σ | 0..* | CodeableConcept | Safety characteristics of the device Safety (Example) |
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
physicalCharacteristics | 0..1 | ProdCharacteristic | Physical characteristics to define or specify the product - for example dimensions, color etc. | |
languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |
capability | 0..* | BackboneElement | Additional capabilities of the device | |
type | 1..1 | CodeableConcept | The type of capability - whether it is a physical attribute, a customization needed | |
description | 0..* | CodeableConcept | The actual capability of the device | |
property | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |
type | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |
valueQuantity | 0..* | Quantity | Property value as a quantity | |
valueCode | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |
owner | 0..1 | Reference(Organization) | Organization responsible for device | |
contact | 0..* | ContactPoint | Details for human/organization for support | |
onlineInformation | 0..1 | uri | Access to on-line information | |
note | 0..* | Annotation | Device notes and comments | |
parentDevice | Σ | 0..1 | Reference(DeviceDefinition) | The parent device it can be part of |
material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | |
substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | |
alternate | 0..1 | boolean | Indicates an alternative material of the device | |
allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen | |
Documentation for this format |
XML Template
<DeviceDefinition xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Instance identifier --></identifier> <udiDeviceIdentifier> <!-- 0..* Unique Device Identifier (UDI) Barcode string --> <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier --> <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm --> <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies --> </udiDeviceIdentifier> <manufacturer[x]><!-- 0..1 string|Reference(Organization) Name of device manufacturer --></manufacturer[x]> <deviceName> <!-- 0..* The name or names of the device as given by the manufacturer --> <name value="[string]"/><!-- 1..1 A name that is used to refer to the device --> <type value="[code]"/><!-- 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other --> </deviceName> <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer --> <type><!-- 0..* CodeableConcept What kind of device or device system this is --></type> <specialization> <!-- 0..* The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication --> <systemType value="[string]"/><!-- 1..1 The standard that is used to operate and communicate --> <version value="[string]"/><!-- 0..1 The version of the standard that is used to operate and communicate --> </specialization> <hasPart> <!-- 0..* A device, part of the current one --> <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference> <count value="[integer]"/><!-- 0..1 Number of occurrences of the part --> </hasPart> <packaging> <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged --> <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier> <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type> <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) --> <distributor> <!-- 0..* An organization that distributes the packaged device --> <name value="[string]"/><!-- 0..1 Distributor's human-readable name --> <organizationReference><!-- 0..* Reference Distributor as an Organization resource --></organizationReference> </distributor> <udiDeviceIdentifier> <!-- 0..* Unique Device Identifier (UDI) Barcode string on the packaging --> <deviceIdentifier value="[string]"/><!-- 1..1 Identifier to be associated with every instance for issuer and jurisdiction --> <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm --> <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies --> </udiDeviceIdentifier> <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging> </packaging> <version> <!-- 0..* The version of the device or software --> <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </version> <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <physicalCharacteristics><!-- 0..1 ProdCharacteristic Physical characteristics to define or specify the product - for example dimensions, color etc. --></physicalCharacteristics> <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode> <capability> <!-- 0..* Additional capabilities of the device --> <type><!-- 1..1 CodeableConcept The type of capability - whether it is a physical attribute, a customization needed --></type> <description><!-- 0..* CodeableConcept The actual capability of the device --></description> </capability> <property> <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties --> <type><!-- 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible) --></type> <valueQuantity><!-- 0..* Quantity Property value as a quantity --></valueQuantity> <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode> </property> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <onlineInformation value="[uri]"/><!-- 0..1 Access to on-line information --> <note><!-- 0..* Annotation Device notes and comments --></note> <parentDevice><!-- 0..1 Reference(DeviceDefinition) The parent device it can be part of --></parentDevice> <material> <!-- 0..* A substance used to create the material(s) of which the device is made --> <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance> <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device --> <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen --> </material> </DeviceDefinition>
JSON Template
{ "resourceType" : "DeviceDefinition", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // Instance identifier "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string "deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier "issuer" : "<uri>", // R! The organization that assigns the identifier algorithm "jurisdiction" : "<uri>" // R! The jurisdiction to which the deviceIdentifier applies }], // manufacturer[x]: Name of device manufacturer. One of these 2: "manufacturerString" : "<string>", "manufacturerReference" : { Reference(Organization) }, "deviceName" : [{ // The name or names of the device as given by the manufacturer "name" : "<string>", // R! A name that is used to refer to the device "type" : "<code>" // R! udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other }], "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer "type" : [{ CodeableConcept }], // What kind of device or device system this is "specialization" : [{ // The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication "systemType" : "<string>", // R! The standard that is used to operate and communicate "version" : "<string>" // The version of the standard that is used to operate and communicate }], "hasPart" : [{ // A device, part of the current one "reference" : { Reference(DeviceDefinition) }, // R! Reference to the part "count" : <integer> // Number of occurrences of the part }], "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged "identifier" : { Identifier }, // Business identifier of the packaged medication "type" : { CodeableConcept }, // A code that defines the specific type of packaging "count" : <integer>, // The number of items contained in the package (devices or sub-packages) "distributor" : [{ // An organization that distributes the packaged device "name" : "<string>", // Distributor's human-readable name "organizationReference" : [{ Reference }] // Distributor as an Organization resource }], "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string on the packaging "deviceIdentifier" : "<string>", // R! Identifier to be associated with every instance for issuer and jurisdiction "issuer" : "<uri>", // R! The organization that assigns the identifier algorithm "jurisdiction" : "<uri>" // R! The jurisdiction to which the deviceIdentifier applies }], "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages }], "version" : [{ // The version of the device or software "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal "component" : { Identifier }, // The hardware or software module of the device to which the version applies "value" : "<string>" // R! The version text }], "safety" : [{ CodeableConcept }], // Safety characteristics of the device "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information "physicalCharacteristics" : { ProdCharacteristic }, // Physical characteristics to define or specify the product - for example dimensions, color etc. "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported) "capability" : [{ // Additional capabilities of the device "type" : { CodeableConcept }, // R! The type of capability - whether it is a physical attribute, a customization needed "description" : [{ CodeableConcept }] // The actual capability of the device }], "property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties "type" : { CodeableConcept }, // R! Code that specifies the property DeviceDefinitionPropetyCode (Extensible) "valueQuantity" : [{ Quantity }], // Property value as a quantity "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP) }], "owner" : { Reference(Organization) }, // Organization responsible for device "contact" : [{ ContactPoint }], // Details for human/organization for support "onlineInformation" : "<uri>", // Access to on-line information "note" : [{ Annotation }], // Device notes and comments "parentDevice" : { Reference(DeviceDefinition) }, // The parent device it can be part of "material" : [{ // A substance used to create the material(s) of which the device is made "substance" : { CodeableConcept }, // R! A relevant substance that the device contains, may contain, or is made of "alternate" : <boolean>, // Indicates an alternative material of the device "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen }] }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:DeviceDefinition; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:DeviceDefinition.identifier [ Identifier ], ... ; # 0..* Instance identifier fhir:DeviceDefinition.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string fhir:DeviceDefinition.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier fhir:DeviceDefinition.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm fhir:DeviceDefinition.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies ], ...; # DeviceDefinition.manufacturer[x] : 0..1 Name of device manufacturer. One of these 2 fhir:DeviceDefinition.manufacturerString [ string ] fhir:DeviceDefinition.manufacturerReference [ Reference(Organization) ] fhir:DeviceDefinition.deviceName [ # 0..* The name or names of the device as given by the manufacturer fhir:DeviceDefinition.deviceName.name [ string ]; # 1..1 A name that is used to refer to the device fhir:DeviceDefinition.deviceName.type [ code ]; # 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other ], ...; fhir:DeviceDefinition.modelNumber [ string ]; # 0..1 The catalog or model number for the device for example as defined by the manufacturer fhir:DeviceDefinition.type [ CodeableConcept ], ... ; # 0..* What kind of device or device system this is fhir:DeviceDefinition.specialization [ # 0..* The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication fhir:DeviceDefinition.specialization.systemType [ string ]; # 1..1 The standard that is used to operate and communicate fhir:DeviceDefinition.specialization.version [ string ]; # 0..1 The version of the standard that is used to operate and communicate ], ...; fhir:DeviceDefinition.hasPart [ # 0..* A device, part of the current one fhir:DeviceDefinition.hasPart.reference [ Reference(DeviceDefinition) ]; # 1..1 Reference to the part fhir:DeviceDefinition.hasPart.count [ integer ]; # 0..1 Number of occurrences of the part ], ...; fhir:DeviceDefinition.packaging [ # 0..* Information about the packaging of the device, i.e. how the device is packaged fhir:DeviceDefinition.packaging.identifier [ Identifier ]; # 0..1 Business identifier of the packaged medication fhir:DeviceDefinition.packaging.type [ CodeableConcept ]; # 0..1 A code that defines the specific type of packaging fhir:DeviceDefinition.packaging.count [ integer ]; # 0..1 The number of items contained in the package (devices or sub-packages) fhir:DeviceDefinition.packaging.distributor [ # 0..* An organization that distributes the packaged device fhir:DeviceDefinition.packaging.distributor.name [ string ]; # 0..1 Distributor's human-readable name fhir:DeviceDefinition.packaging.distributor.organizationReference [ Reference ], ... ; # 0..* Distributor as an Organization resource ], ...; fhir:DeviceDefinition.packaging.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string on the packaging fhir:DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 Identifier to be associated with every instance for issuer and jurisdiction fhir:DeviceDefinition.packaging.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm fhir:DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies ], ...; fhir:DeviceDefinition.packaging.packaging [ See DeviceDefinition.packaging ], ... ; # 0..* Allows packages within packages ], ...; fhir:DeviceDefinition.version [ # 0..* The version of the device or software fhir:DeviceDefinition.version.type [ CodeableConcept ]; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:DeviceDefinition.version.component [ Identifier ]; # 0..1 The hardware or software module of the device to which the version applies fhir:DeviceDefinition.version.value [ string ]; # 1..1 The version text ], ...; fhir:DeviceDefinition.safety [ CodeableConcept ], ... ; # 0..* Safety characteristics of the device fhir:DeviceDefinition.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information fhir:DeviceDefinition.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Physical characteristics to define or specify the product - for example dimensions, color etc. fhir:DeviceDefinition.languageCode [ CodeableConcept ], ... ; # 0..* Language code for the human-readable text strings produced by the device (all supported) fhir:DeviceDefinition.capability [ # 0..* Additional capabilities of the device fhir:DeviceDefinition.capability.type [ CodeableConcept ]; # 1..1 The type of capability - whether it is a physical attribute, a customization needed fhir:DeviceDefinition.capability.description [ CodeableConcept ], ... ; # 0..* The actual capability of the device ], ...; fhir:DeviceDefinition.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties fhir:DeviceDefinition.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property DeviceDefinitionPropetyCode (Extensible) fhir:DeviceDefinition.property.valueQuantity [ Quantity ], ... ; # 0..* Property value as a quantity fhir:DeviceDefinition.property.valueCode [ CodeableConcept ], ... ; # 0..* Property value as a code, e.g., NTP4 (synced to NTP) ], ...; fhir:DeviceDefinition.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device fhir:DeviceDefinition.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support fhir:DeviceDefinition.onlineInformation [ uri ]; # 0..1 Access to on-line information fhir:DeviceDefinition.note [ Annotation ], ... ; # 0..* Device notes and comments fhir:DeviceDefinition.parentDevice [ Reference(DeviceDefinition) ]; # 0..1 The parent device it can be part of fhir:DeviceDefinition.material [ # 0..* A substance used to create the material(s) of which the device is made fhir:DeviceDefinition.material.substance [ CodeableConcept ]; # 1..1 A relevant substance that the device contains, may contain, or is made of fhir:DeviceDefinition.material.alternate [ boolean ]; # 0..1 Indicates an alternative material of the device fhir:DeviceDefinition.material.allergenicIndicator [ boolean ]; # 0..1 Whether the substance is a known or suspected allergen ], ...; ]
Changes since Release 3
DeviceDefinition | |
DeviceDefinition.deviceName.type |
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DeviceDefinition.type |
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DeviceDefinition.hasPart |
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DeviceDefinition.hasPart.reference |
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DeviceDefinition.hasPart.count |
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DeviceDefinition.packaging |
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DeviceDefinition.packaging.identifier |
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DeviceDefinition.packaging.type |
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DeviceDefinition.packaging.count |
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DeviceDefinition.packaging.distributor |
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DeviceDefinition.packaging.distributor.name |
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DeviceDefinition.packaging.distributor.organizationReference |
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DeviceDefinition.packaging.udiDeviceIdentifier |
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DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier |
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DeviceDefinition.packaging.udiDeviceIdentifier.issuer |
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DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction |
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DeviceDefinition.packaging.packaging |
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DeviceDefinition.version |
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DeviceDefinition.version.type |
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DeviceDefinition.version.component |
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DeviceDefinition.version.value |
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DeviceDefinition.url |
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DeviceDefinition.quantity |
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See the Full Difference for further information
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a
Path | Definition | Type | Reference |
---|---|---|---|
DeviceDefinition.deviceName.type | Required | DeviceNameType | |
DeviceDefinition.type | Example | DeviceType | |
DeviceDefinition.safety | Example | http://hl7.org/fhir/ValueSet/device-safety |
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
Name | Type | Description | Expression | In Common |
identifier | token | The identifier of the component | DeviceDefinition.identifier | |
parent | reference | The parent DeviceDefinition resource | DeviceDefinition.parentDevice (DeviceDefinition) | |
type | token | The device component type | DeviceDefinition.type |