Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
= Must Support, = Is Modifier, = QiCore defined extension
Field | Card. | Type | Description |
---|---|---|---|
deviceIdentifier | 0..1 | String | 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. |
issuer | 0..1 | String | Organization that is 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. |
jurisdiction | 0..1 | String | 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. |
carrierAIDC | 0..1 | String | The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of 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 base64 encoded. |
carrierHRF | 0..1 | String | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. |
entryType | 0..1 | String | A coded entry to indicate how the data was entered. Binding: Codes to identify how UDI data was entered. (required) |