http://hl7.org/fhir/StructureDefinition/DeviceDefinition|5.0.0
This is a specialized resource that defines the characteristics and capabilities of a device.
| Name | Flags | Card | Type | Description & Constraints |
|---|---|---|---|---|
DeviceDefinition | 0..* | An instance of a medical-related component of a medical device | ||
| 0..1 | markdown | Additional information to describe the device | ||
Σ | 0..* | Identifier | Instance identifier | |
| 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | ||
| 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 | ||
| 1..1 | uri | The organization that assigns the identifier algorithm | ||
| 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | ||
| 0..* | BackboneElement | Indicates whether and when the device is available on the market | ||
| 1..1 | Period | Begin and end dates for the commercial distribution of the device | ||
| 1..1 | uri | National state or territory where the device is commercialized | ||
| 0..* | BackboneElement | Regulatory identifier(s) associated with this device | ||
| 1..1 | code | basic | master | license DeviceRegulatoryIdentifierType (required) | ||
| 1..1 | string | The identifier itself | ||
| 1..1 | uri | The organization that issued this identifier | ||
| 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | ||
| 0..1 | string | The part number or catalog number of the device | ||
Σ | 0..1 | Reference | Name of device manufacturer | |
Σ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer | |
Σ | 1..1 | string | A name that is used to refer to the device | |
Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name DeviceNameType (required) | |
Σ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer | |
Σ | 0..* | BackboneElement | What kind of device or device system this is | |
Σ | 1..1 | CodeableConcept | A classification or risk class of the device model DeviceKind (example) | |
| 0..* | RelatedArtifact | Further information qualifying this classification of the device model | ||
Σ | 0..* | BackboneElement | Identifies the standards, specifications, or formal guidances for the capabilities supported by the device | |
Σ | 0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance DeviceSpecificationCategory (example) | |
Σ | 1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type DeviceSpecificationType (example) | |
Σ | 0..* | string | The specific form or variant of the standard, specification or formal guidance | |
| 0..* | RelatedArtifact | Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance | ||
Σ | 0..* | BackboneElement | A device, part of the current one | |
Σ | 1..1 | Reference | Reference to the part | |
| 0..1 | integer | Number of occurrences of the part | ||
| 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | ||
| 0..1 | Identifier | Business identifier of the packaged medication | ||
| 0..1 | CodeableConcept | A code that defines the specific type of packaging | ||
| 0..1 | integer | The number of items contained in the package (devices or sub-packages) | ||
| 0..* | BackboneElement | An organization that distributes the packaged device | ||
| 0..1 | string | Distributor's human-readable name | ||
| 0..* | Reference | Distributor as an Organization resource | ||
| 0..* | Unique Device Identifier (UDI) Barcode string on the packaging | |||
| 0..* | Allows packages within packages | |||
| 0..* | BackboneElement | The version of the device or software | ||
| 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | ||
| 0..1 | Identifier | The hardware or software module of the device to which the version applies | ||
| 1..1 | string | The version text | ||
Σ | 0..* | CodeableConcept | Safety characteristics of the device Safety (example) | |
| 0..* | ProductShelfLife | Shelf Life and storage information | ||
| 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | ||
| 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc | ||
| 1..1 | CodeableConcept | Code that specifies the property being represented DevicePropertyType (example) | ||
| 1..1 | Value of the property | |||
| 1..1 | Quantity | |||
| 1..1 | CodeableConcept | |||
| 1..1 | string | |||
| 1..1 | boolean | |||
| 1..1 | integer | |||
| 1..1 | Range | |||
| 1..1 | Attachment | |||
| 0..1 | Reference | Organization responsible for device | ||
| 0..* | ContactPoint | Details for human/organization for support | ||
| 0..* | BackboneElement | An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device | ||
| 1..1 | Coding | The type indicates the relationship of the related device to the device instance DeviceDefinitionRelationType (extensible) | ||
| 1..1 | CodeableReference | A reference to the linked device | ||
| 0..* | Annotation | Device notes and comments | ||
| 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | ||
| 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | ||
| 0..1 | boolean | Indicates an alternative material of the device | ||
| 0..1 | boolean | Whether the substance is a known or suspected allergen | ||
| 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version DeviceProductionIdentifierInUDI (required) | ||
| 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device | ||
| 0..* | UsageContext | The circumstances that form the setting for using the device | ||
| 0..1 | markdown | Detailed written and visual directions for the user on how to use the device | ||
| 0..* | RelatedArtifact | A source of information or reference for this guideline | ||
| 0..* | CodeableConcept | A clinical condition for which the device was designed to be used | ||
| 0..* | CodeableConcept | A specific situation when a device should not be used because it may cause harm | ||
| 0..* | CodeableConcept | Specific hazard alert information that a user needs to know before using the device | ||
| 0..1 | string | A description of the general purpose or medical use of the device or its function | ||
| 0..1 | BackboneElement | Tracking of latest field safety corrective action | ||
| 1..1 | boolean | Whether the corrective action was a recall | ||
| 0..1 | code | model | lot-numbers | serial-numbers DeviceCorrectiveActionScope (required) | ||
| 1..1 | Period | Start and end dates of the corrective action | ||
| 0..* | BackboneElement | Billing code or reference associated with the device | ||
| 1..1 | CodeableReference | The code or reference for the charge item | ||
| 1..1 | Quantity | Coefficient applicable to the billing code | ||
| 0..1 | Period | A specific time period in which this charge item applies | ||
| 0..* | UsageContext | The context to which this charge item applies |