This resource identifies an instance or a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices includes include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

Allows institutions to track their devices.

Unique instance identifiers assigned to a device by organizations like manufacturers other organizations or owners. If the identifier identifies the type of device, Device.type should be used.

Often fixed to the device as The barcode string from a barcode and present on a device label or package may identify the instance, include names given to the device in local usage. Note that some usage, or may identify the type of device. If the barcodes affixed to identifier identifies the device identify its type, not its instance. type of device, Device.type element should be used. For UDI , this element corresponds to the FDA mandated Unique Device Identifier (UDI) use variable portion of the Device.udi element. UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

Code or Unique device identifier (UDI) assigned to device label or package.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Name of device as used in labeling or catalog.

Use the Device.type for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'.

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the nature string with DI first and in order of human readable expression on label.

The full UDI carrier of the device Automatic Identification and Data Capture (AIDC) technology representation of the kind barcode string as printed on the packaging of functionality/services/behavior that may the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be expected from it.) base64 encoded.

For The AIDC form of UDIs should be scanned or otherwise used for the FDA mandated Unique Device Identifier (UDI) use identification of the Device.udi element. device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Descriptive information, usage information or implantation information Organization that is not captured in an existing element. charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.

A coded entry to indicate how the data was entered.

Supports a way to distinguish hand entered from machine read data.

Status of the Device availability.

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

A name Code or identifier to identify a kind of the manufacturer. device.

The "model" is an identifier assigned by the manufacturer to identify the product by its type. This Lot number is shared assigned by the all devices sold as the same type. manufacturer.

The version A name of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware. manufacturer.

The date and time when the device was manufactured.

The date and time beyond which this device is no longer valid or should not be used (if applicable).

United States Food and Drug Administration mandated Unique Device Identifier (UDI). Use The "model" is an identifier assigned by the human readable information (the content that manufacturer to identify the user sees, which product by its type. This number is sometimes different to shared by the exact syntax represented in all devices sold as the barcode) - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm. same type.

The unique identifier may identify an instance of a device uniquely, or it may only identify the type of the device. A portion version of the UDI - device, if the DI part - can be extracted from device has multiple releases under the UDI when required, and used to look up information about same model, or if the device through the GUDID. is software or carries firmware.

Lot number assigned by Patient information, If the manufacturer. device is affixed to a person.

Alphanumeric Maximum 20. If the device is implanted in a patient, then need to associate the device to the patient.

An organization that is responsible for the provision and ongoing maintenance of the device.

The place where Contact details for an organization or a particular human that is responsible for the device can be found. device.

used for troubleshooting etc.

Patient information, if The place where the resource is affixed to a person. device can be found.

Device.location can be used to track device location.

Contact details for an organization or a particular human that is responsible for A network address on which the device. device may be contacted directly.

used for troubleshooting etc. If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

A network address on which the device may be contacted directly. Descriptive information, usage information or implantation information that is not captured in an existing element.

If the device is running a FHIR server, the network address should be the root URL from which Provides additional safety characteristics about a conformance statement may be retrieved. medical device. For example devices containing latex.