UDI is a unique numeric or alphanumeric code that consists of two parts:
(1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and (2)
a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
(2a) the lot or batch number within which a device was manufactured; (2b) the serial number of a specific device; (2c) the expiration date of a specific device; (2d) the date a specific device was manufactured; (2e) the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
| Device |
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| identifier |
The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. |
| definition |
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| udiCarrier |
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| deviceIdentifier |
The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. |
| deviceIdentifierSystem |
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| issuer |
All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other |
| jurisdiction |
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| carrierAIDC |
A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology. |
| carrierHRF |
A unique device identifier (UDI) on a device label in plain text |
| entryType |
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| status |
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| availabilityStatus |
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| biologicalSourceEvent |
A distinct identification code required by §1271.290(c), the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. This may also be known as the donation identification number (DIN) or a value to trace the product's origin. |
| manufacturer |
N/A |
| manufactureDate |
The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. |
| expirationDate |
the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. |
| lotNumber |
The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. |
| serialNumber |
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| name |
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| value |
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| type |
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| display |
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| modelNumber |
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| partNumber |
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| category |
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| type |
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| deviceVersion |
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| type |
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| component |
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| installDate |
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| value |
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| conformsTo |
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| category |
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| specification |
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| version |
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| property |
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| type |
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| value[x] |
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| additive |
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| type |
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| quantity |
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| performer |
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| performed |
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| contact |
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| location |
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| note |
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| safety |
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| parent |
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| Device |
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| identifier |
system = urn:oid
value = DIS System ID characteristic value (8 octets hexadecimal string) |
| definition |
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| udiCarrier |
DIS UDI for Medical Devices characteristic value fields - See Bluetooth GATT Specification Supplement (https://www.bluetooth.com/specifications/gss/) for details) |
| deviceIdentifier |
Device Identifier field from DIS UDI for Medical Devices characteristic |
| deviceIdentifierSystem |
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| issuer |
Issuer field from DIS UDI for Medical Devices characteristic |
| jurisdiction |
Authority field from DIS UDI for Medical Devices characteristic |
| carrierAIDC |
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| carrierHRF |
Label field from DIS UDI for Medical Devices characteristic |
| entryType |
electronic-transmission |
| status |
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| availabilityStatus |
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| biologicalSourceEvent |
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| manufacturer |
DIS Manufacturer Name String characteristic value |
| manufactureDate |
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| expirationDate |
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| lotNumber |
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| serialNumber |
DIS Serial Number String characteristic value |
| name |
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| value |
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| type |
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| display |
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| modelNumber |
DIS Model Number String characteristic value |
| partNumber |
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| category |
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| type |
text = Appearance Value name or Primary Service name
coding = Appearance Value or Primary Service UUID |
| deviceVersion |
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| type |
Bluetooth-UUID |
| component |
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| installDate |
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| value |
DIS Firmware Revision characteristic value or DIS Hardware Revision characteristic value or DIS Software Revision characteristic value |
| conformsTo |
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| category |
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| specification |
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| version |
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| property |
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| type |
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| value[x] |
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| additive |
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| type |
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| quantity |
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| performer |
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| performed |
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| contact |
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| location |
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| note |
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| safety |
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| parent |
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Administration
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