Device Identifier (DI) & Production Identifier (PI)
Device Identifier (DI)
The Device Identifier (DI) is the mandatory, fixed portion of the UDI that identifies the specific version or model of a device. A unique DI must be obtained for each:
- Device labeller manufacturer or (the entity responsible for the labeling and marketing of the device)
- Version or model of the device
- Level of packaging (individual unit, case, pallet)
The DI for the base package (individual unit) is called the Primary DI — this is the DI submitted to the GUDID database.
Production Identifier (PI)
The Production Identifier (PI) is the conditional, variable portion of the UDI. It must include one or more of the following if they appear on the label:
| PI element | Required when |
|---|---|
| Lot or batch number | Device is assigned a lot/batch number |
| Serial number | Device is assigned a serial number |
| Manufacturing date | Date appears on the label |
| Expiration/use-by date | Date appears on the label |
| Distinct identification code (for HCT/Ps) | For human cells, tissues, and cellular/tissue-based products |
Devices exempt from PI
Some devices are exempt from displaying the PI on the label:
- Class I devices exempt from UDI labelling requirements
- Small devices where space limitations make the full UDI impractical (alternative compliance methods apply)