NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TUDomainResourceAn instance of a medical-related component of a medical device

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... description 0..1markdownAdditional information to describe the device
... identifier Σ0..*IdentifierInstance identifier

... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string

.... deviceIdentifier 1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
.... issuer 1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... marketDistribution 0..*BackboneElementIndicates whether and when the device is available on the market

..... marketPeriod 1..1PeriodBegin and end dates for the commercial distribution of the device
..... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... regulatoryIdentifier 0..*BackboneElementRegulatory identifier(s) associated with this device

.... type 1..1codebasic | master | license
Binding: Device Definition Regulatory Identifier Type (Required)
.... deviceIdentifier 1..1stringThe identifier itself
.... issuer 1..1uriThe organization that issued this identifier
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... partNumber 0..1stringThe part number or catalog number of the device
... manufacturer Σ0..1Reference(Organization)Name of device manufacturer
... deviceName Σ0..*BackboneElementThe name or names of the device as given by the manufacturer

.... name Σ1..1stringA name that is used to refer to the device
.... type Σ1..1coderegistered-name | user-friendly-name | patient-reported-name
Binding: Device Name Type (Required)
... modelNumber Σ0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... classification Σ0..*BackboneElementWhat kind of device or device system this is

.... type Σ1..1CodeableConceptA classification or risk class of the device model
Binding: Device Type (Example)
.... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model

... conformsTo Σ0..*BackboneElementIdentifies the standards, specifications, or formal guidances for the capabilities supported by the device

.... category Σ0..1CodeableConceptDescribes the common type of the standard, specification, or formal guidance
Binding: Device Specification Category (Example)
.... specification Σ1..1CodeableConceptIdentifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: Device Specification Type (Example)
.... version Σ0..*stringThe specific form or variant of the standard, specification or formal guidance

.... source 0..*RelatedArtifactStandard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance

... hasPart Σ0..*BackboneElementA device, part of the current one

.... reference Σ1..1Reference(DeviceDefinition)Reference to the part
.... count 0..1integerNumber of occurrences of the part
... packaging 0..*BackboneElementInformation about the packaging of the device, i.e. how the device is packaged

.... identifier 0..1IdentifierBusiness identifier of the packaged medication
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count 0..1integerThe number of items contained in the package (devices or sub-packages)
.... distributor 0..*BackboneElementAn organization that distributes the packaged device

..... name 0..1stringDistributor's human-readable name
..... organizationReference 0..*Reference(Organization)Distributor as an Organization resource

.... udiDeviceIdentifier 0..*see udiDeviceIdentifierUnique Device Identifier (UDI) Barcode string on the packaging

.... packaging 0..*see packagingAllows packages within packages

... version 0..*BackboneElementThe version of the device or software

.... type 0..1CodeableConceptThe type of the device version, e.g. manufacturer, approved, internal
.... component 0..1IdentifierThe hardware or software module of the device to which the version applies
.... value 1..1stringThe version text
... safety Σ0..*CodeableConceptSafety characteristics of the device
Binding: Device Safety (Example)

... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information

... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)

... property 0..*BackboneElementInherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

.... type 1..1CodeableConceptCode that specifies the property being represented
Binding: Device Property Type (Example)
.... value[x] 1..1Value of the property
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueAttachmentAttachment
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support

... link 0..*BackboneElementAn associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device

.... relation 1..1CodingThe type indicates the relationship of the related device to the device instance
Binding: Device Definition Relation Type (Extensible)
.... relatedDevice 1..1CodeableReference(DeviceDefinition)A reference to the linked device
... note 0..*AnnotationDevice notes and comments

... material 0..*BackboneElementA substance used to create the material(s) of which the device is made

.... substance 1..1CodeableConceptA relevant substance that the device contains, may contain, or is made of
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..*codelot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: Device Production Identifier In UDI (Required)

... guideline 0..1BackboneElementInformation aimed at providing directions for the usage of this model of device
.... useContext 0..*UsageContextThe circumstances that form the setting for using the device

.... usageInstruction 0..1markdownDetailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..*RelatedArtifactA source of information or reference for this guideline

.... indication 0..*CodeableConceptA clinical condition for which the device was designed to be used

.... contraindication 0..*CodeableConceptA specific situation when a device should not be used because it may cause harm

.... warning 0..*CodeableConceptSpecific hazard alert information that a user needs to know before using the device

.... intendedUse 0..1stringA description of the general purpose or medical use of the device or its function
... correctiveAction 0..1BackboneElementTracking of latest field safety corrective action
.... recall 1..1booleanWhether the corrective action was a recall
.... scope 0..1codemodel | lot-numbers | serial-numbers
Binding: Device Corrective Action Scope (Required)
.... period 1..1PeriodStart and end dates of the corrective action
... chargeItem 0..*BackboneElementBilling code or reference associated with the device

.... chargeItemCode 1..1CodeableReference(ChargeItemDefinition)The code or reference for the charge item
.... count 1..1QuantityCoefficient applicable to the billing code
.... effectivePeriod 0..1PeriodA specific time period in which this charge item applies
.... useContext 0..*UsageContextThe context to which this charge item applies


doco Documentation for this format