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 |