UDI Compliance: What Format Does the Unit of Use DI Need to Be?

The Unit of Use Device Identifier (DI) must be the same format and from the same issuing agency as the Primary DI. So, if your company uses GS1 for labeling and you apply a G10 to the primary DI, then your Unit of Use DI also must contain a G10.

The Primary DI is the identifier on the label of the package. The Unit of Use DI is the identifier on devices inside the package, if there is more than one device inside. Unit of Use DIs only apply to devices subject to the Unit of Use DI.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.