Device identification

The type of device is identified with a code known as a Device Identifier (DI). 

Production identification

Production identification refers to the information that identifies a medical device to a more granular level, either to an instance by using a serial number or by using batch number and dates. This is known as the Production Identifier (PI).  

This production information will change dynamically for every manufacturing batch.

Common PIs used on medical devices include: 

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Lot/batch number 

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Serial number

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Expiry date

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Manufacturing date

When we look at these identification codes in relation to the UDI regulations, they are known respectively as UDI-DI and UDI-PI.

The specific production information cannot be entered into any regulatory databases - you normally indicate what types of production information are included on the label and in the barcode.  

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GS1 do not specify which production identifiers need to be included for medical devices. Requirements can vary by market and risk class. Manufacturers should seek guidance from the applicable regulators.

You can learn more about GS1 standards and UDI on the GS1 Global Office website.