Device Identifier (DI) and Production Identifier (PI)
Device Identifier (DI) — 기기식별자
- Identifies the specific version or model of a device
- Issued by an authorised issuing agency (GS1 Korea or HIBCC)
- Must be registered in KIMS with the device's key attributes
- The same for every unit of a given device model/variant
Production Identifier (PI) — 생산식별자
Variable portion that includes one or more of:
- Lot / batch number — for most devices
- Serial number — mandatory for implantable and high-risk devices
- Expiry date — for devices with limited shelf life (e.g., sterile devices)
- Manufacturing date — where required
Label requirements by device type
| Device type | DI | Lot/Batch | Serial | Expiry |
|---|---|---|---|---|
| Non-sterile, non-implantable | ✓ | ✓ | Optional | Optional |
| Sterile devices | ✓ | ✓ | Optional | ✓ |
| Implantable devices | ✓ | ✓ | ✓ | ✓ (if applicable) |