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
description		0..1	markdown	Additional information to describe the device
identifier	Σ	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 jurisdiction provided 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
marketDistribution		0..*	BackboneElement	Indicates whether and when the device is available on the market
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
regulatoryIdentifier		0..*	BackboneElement	Regulatory identifier(s) associated with this device
type		1..1	code	basic | master | license Binding: Device Definition Regulatory Identifier Type ( Required)
deviceIdentifier		1..1	string	The identifier itself
issuer		1..1	uri	The organization that issued this identifier
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
partNumber		0..1	string	The part number or catalog number of the device
manufacturer	Σ	0..1	Reference( Organization)	Name of device manufacturer
deviceName	Σ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
name	Σ	1..1	string	A name that is used to refer to the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: Device Name Type ( Required)
modelNumber	Σ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
classification	Σ	0..*	BackboneElement	What kind of device or device system this is
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: Device Type ( Example)
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model
conformsTo	Σ	0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
category	Σ	0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance Binding: Device Specification Category ( Example)
specification	Σ	1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: Device Specification Type ( Example)
version	Σ	0..*	string	The specific form or variant of the standard, specification or formal guidance
source		0..*	RelatedArtifact	Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
hasPart	Σ	0..*	BackboneElement	A device, part of the current one
reference	Σ	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( Organization)	Distributor as an Organization resource
udiDeviceIdentifier		0..*	see udiDeviceIdentifier	Unique Device Identifier (UDI) Barcode string on the packaging
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 Binding: Device Safety ( Example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: Device Property Type ( Example)
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
owner		0..1	Reference( Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
link		0..*	BackboneElement	An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
relation		1..1	Coding	The type indicates the relationship of the related device to the device instance Binding: Device Definition Relation Type ( Extensible)
relatedDevice		1..1	CodeableReference( DeviceDefinition)	A reference to the linked device
note		0..*	Annotation	Device notes and comments
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
productionIdentifierInUDI		0..*	code	lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: Device Production Identifier In UDI ( Required)
guideline		0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
useContext		0..*	UsageContext	The circumstances that form the setting for using the device
usageInstruction		0..1	markdown	Detailed written and visual directions for the user on how to use the device
relatedArtifact		0..*	RelatedArtifact	A source of information or reference for this guideline
indication		0..*	CodeableConcept	A clinical condition for which the device was designed to be used
contraindication		0..*	CodeableConcept	A specific situation when a device should not be used because it may cause harm
warning		0..*	CodeableConcept	Specific hazard alert information that a user needs to know before using the device
intendedUse		0..1	string	A description of the general purpose or medical use of the device or its function
correctiveAction		0..1	BackboneElement	Tracking of latest field safety corrective action
recall		1..1	boolean	Whether the corrective action was a recall
scope		0..1	code	model | lot-numbers | serial-numbers Binding: Device Corrective Action Scope ( Required)
period		1..1	Period	Start and end dates of the corrective action
chargeItem		0..*	BackboneElement	Billing code or reference associated with the device
chargeItemCode		1..1	CodeableReference( ChargeItemDefinition)	The code or reference for the charge item
count		1..1	Quantity	Coefficient applicable to the billing code
effectivePeriod		0..1	Period	A specific time period in which this charge item applies
useContext		0..*	UsageContext	The context to which this charge item applies
Documentation for this format