Generate a Unique Device Identifier for Lot and Serial-Controlled Manufactured Products

Medical device manufacturers need to comply with regulations to manage, generate, and store a Unique Device Identifier (UDI). The UDI is a series of numeric or alphanumeric characters that's assigned to uniquely identify a medical device. It was introduced to improve the identification, traceability, and safety of medical devices. With this feature, you can generate a complete UDI comprised of the following information:

  • Device Identifier - fixed and mandatory element of the UDI. It uniquely identifies the specific version or model of a medical device and the manufacturer (information managed in Oracle Fusion Cloud Product Lifecycle Management).
  • Production Identifier - conditional and variable component of the UDI, which may include information like the lot or batch number, the serial number, the expiration date, and the manufacturing date of the device (managed in Oracle Fusion Cloud Manufacturing).

The UDI generation logic is defined on attributes at the item level:

  • GTIN value
  • Lot
  • Serial number
  • Expiration date
  • Manufacturing date

The UDI is generated as part of the work order product completion and the generated UDI can be seen in the following tasks:

  • Production transaction history
  • Product labels generated during operation transactions
  • Electronic production record

The generation and storage of a full UDI string enables in

  • Efficient tracking and tracing of medical devices throughout their lifecycle
  • Adherence to regulatory requirements and standards for safety and quality
  • Minimizing risks associated with device errors, recalls, and patient safety

UDI in Product label

UDI in Product label

Steps to Enable

Associate a Global Trade Identification Number (GTIN) with the item. The GTIN must be associated to the primary UOM of the item without any party.

Set up the UDI Enabled attribute as Yes and Issuing Agency as GS1 in the UDI page of an item definition. Select the required production identifier attributes such as Manufacturing Date and Expiration date. Expiration date is applicable only for lot-controlled products.

Set up the item as lot-controlled or serial-controlled with serial generation as Predefined serial number or Dynamic entry at inventory receipt or both lot and serial controlled at the item-organization.

Tips And Considerations

UDI when generated for a lot is never updated. UDI for a serial is regenerated when the serial is reversed and completed again.

Access Requirements

Users who are assigned a configured job role that contains this privilege can access this feature:

  • Report Operation Transactions (WIP_REPORT_OPERATION_TRANSACTIONS_PRIV)

This privilege was available prior to this update.