FDA UDI

FDA UDI & GS1

To meet FDA UDI barcode format requirements, companies may follow one of three standards systems: GS1, HIBCC, and ICCBBA.

FDA UDI

The GS1 system has emerged as a front-runner thanks largely to its already global reach and adoption in a number of overlapping markets. The standards cover the formatting, dimensions, and print quality for barcode symbols carrying UDI data, as well as the numbering system used to uniquely identify devices and the data formatting for relevant data fields.

One of the most common GS1-related barcodes is the UPC.  This is used to identify retail products throughout the world.  It is already in use on many medical devices that are sold in a retail setting.

The two other common GS1 barcodes used in UDI are the GS1-128 linear barcode and the GS1 Data Matrix 2D barcode (Learn more about linear vs 2D here):

FDA UDI

FDA UDI

Identification Labs maintains a highly experienced team which can assist companies with barcode and packaging certification, data validation, and data migration.

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