Device
A manufactured instrument, apparatus, machine, software, implant or similar item that is intended for use in the monitoring, diagnosis, prevention, mitigation or alleviation of a health condition or injury.
Note: this includes non-medical devices (e.g., a cane, cell phone).
The organization that manufactures non-medical devices is generally not a Health Care Product Manufacturing Organization (such organizations manufacture only medical devices).
Appears in
Constraints
n/a
Stereotype(s)
n/a
Attributes
| Attribute | Type | Multiplicity | Attribute note |
|---|---|---|---|
| Device Instance Identifier | Identifier | 0..* | Unique business instance identifier(s) assigned to a device by manufacturers, other organizations, or owners. |
| Device Type Code | Codeable Concept | 0..* | Uniquely specifies the kind(s) or type(s) of device. A device instance may have more than one type, in which case these are the types that apply to the specific instance of the device.
Examples: blood pressure cuff, electro-cardiograph, weight scale, dental implant, dual-chamber implantable pacemaker.
Value Set: To be developed. |
| Device Category Code | Codeable Concept | 0..* | Uniquely specifies the high-level grouping of the device.
Examples: Implantable, Home use, Point of care.
Value Set:
https://hl7.org/fhir/R5/valueset-device-category.html |
| Device Manufacture Date | Date | 0..1 | The date the device was manufactured. |
| Device Expiration Date Time | Date Time | 0..1 | The date and (if known) time beyond which this device is no longer valid or should not be used. |
| Device Lot Number | String | 0..1 | Device lot number assigned by the manufacturer. |
| Device Serial Number | String | 0..1 | Serial number assigned by the manufacturer. |
| Device Model Number | String | 0..1 | The manufacturer's model number for the device. |
| Device Part Number | String | 0..1 | The part number or catalog number of the device. |
| Device Status Code | Codeable Concept | 1 | Uniquely specifies the current operational status of the device (e.g., a pacemaker implanted in a patient may be active; a hip implant that was surgically removed is inactive).
Examples: active, inactive, entered-in-error, unknown.
Value Set:
https://hl7.org/fhir/R4B/valueset-device-status.html |
| Device Status Reason Code | Codeable Concept | 0..1 | Uniquely specifies the reason for the current device status (e.g., removed, unavailable).
Value Set:
https://hl7.org/fhir/R4B/valueset-device-status-reason.html |
| Device Availability Status Code | Codeable Concept | 0..1 | Uniquely specifies the device availability status.
Examples: lost, damaged, destroyed, available
Value Set:
https://hl7.org/fhir/R5/valueset-device-availability-status.html |
| Device Safety Feature Code | Codeable Concept | 0..* | Uniquely specifies the constraints, risks, and limitations of the device.
Examples: Magnetic Resonance Safe, Magnetic Resonance Unsafe, Labeled as Containing Natural Rubber Latex
Value Set: To be developed. |
Relationships
| From class | From multiplicity | Relationship | To class | To multiplicity |
|---|---|---|---|---|
| Device | 1 | has | Device Name | 1..* |
| Device | 0..1 | has | Document Reference | 0..* |
| Device | 0..1 | subject of | Observation | 0..* |
| Artificial Intelligence | is a | Device | ||
| Device | 1 | has | Regulatory Device UDI | 0..* |
| Health Care Service Party Role Location | 0..* | has | Device | 0..* |
| Device | is a | Party | ||
| Observation Data Absent Reason | 0..* | for | Device | 0..1 |
| Device | 0..* | at | Location | 0..1 |
| Device | 0..1 | has (composition) | Clinical Annotation | 0..* |
| Device | 1 | has | Device Usage | 0..* |
| Device | 0..1 | has (composition) | Device | 0..* |
| Device | 0..1 | subject of | Service Request | 0..* |
| Device | 0..1 | has | Contact Mechanism | 0..* |
| Observation | 0..* | generated by | Device | 0..1 |
| Device | 0..* | manufactured by | Organization | 0..1 |
| Device | 0..* | owned by | Health Care Organization | 0..1 |
Contact us
If you have questions about this initiative, would like to be added to our stakeholder notification list or would like to participate in our consultations, please email us.
How to cite:
Canadian Institute for Health Information. Device. Accessed November 02, 2026.
