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Creating a UDI

For medical device companies only: This article is designed to provide the basic steps needed to create the “Device Identifier” (DI) segment of Unique Device Identification (UDI) using GS1 US Data Hub® | Product

In GS1 US Data Hub, you can create and share the GTIN associated with your products. To understand the regulations, please refer to our GS1 US Healthcare page, and click the resources provided to determine how you are going to structure your GTIN hierarchy. You may also reference the GS1 US Implementation Guideline for more information on Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI). 

To create the primary device in Data Hub, you need to follow the instructions in the general Create a Product article. Begin by selecting "Regulated Healthcare" when choosing the industry. This ensures that the product is categorized correctly for healthcare regulations. You will then assign a Global Trade Item Number (GTIN) to the primary device, which is the lowest level of a product marked with the identifier.

 

Contact your regulatory department if you are unsure if your items are Regulated Healthcare Trade Items.  The GS1 General Specifications defines Regulated Healthcare Trade Items as:

Regulated healthcare retail consumer trade item:  A regulated healthcare trade item to be sold to the end consumer at a healthcare retail point-of-sale (POS) (pharmacy). They are identified with a GTIN-13, GTIN-12 or GTIN-8 utilizing linear or 2D matrix barcodes that can be scanned by image-based scanners.

Regulated healthcare non-retail consumer trade item:  A consumer trade item not intended for scanning at POS and identified with a GTIN-14, GTIN-13, GTIN-12 or GTIN-8 utilizing linear or 2D matrix barcodes that can be scanned by image-based scanners.
 
Regulated healthcare trade item: Pharmaceuticals or medical devices that are sold or dispensed in a controlled environment (e.g. retail pharmacy, hospital pharmacy). 

If your primary device count is greater than one, you have two options for assigning the Unit of Use Device Identifier (DI).

Option #1 is to select the "Unit of Use" packaging level, which conserves the GTIN capacity by assigning a GTIN-14 with the same item reference as the primary device DI. Please note that you must first enable the Unit of Use Packaging Level in the Data Hub Settings section of GS1 US Data Hub.

Option #2 is to select the "Each" packaging level for the Unit of Use item, which is beneficial if the individual device could become a saleable unit at some point.

Identifying the lowest item in the hierarchy as a "unit of use" conserves the GTIN capacity by allowing the Unit of Use DI to be assigned a GTIN-14 with the same item reference as the primary device DI. This option is useful for viewing the association of the Unit of Use DI with the primary device when viewing the product hierarchy. On the other hand, identifying the lowest item as an "each" assigns a GTIN-12 and allows for the possibility of generating a UPC-A barcode if the individual device becomes a saleable unit.

To enable the Unit of Use packaging level in GS1 US Data Hub, you must have the General User Administrator role for your company. Go to the Data Hub Settings under the Profile Icon, click on the Product (GTIN) Unit of Use link, check the box for "Enable Unit of Use Packaging Level," and click Save Settings. Once enabled, this packaging level will be available when adding new products.

To build a product hierarchy in Data Hub, follow the instructions in the general product hierarchy article. Ensure that you select "Regulated Healthcare" as the industry. You can create higher-level packaging items by adding new products and associating them with the primary device. This involves assigning GTINs to each level of the hierarchy.

Yes, you can import products in bulk using the Product Import Template in GS1 US Data Hub. Follow instructions to the How to Import Products article. 

You have two template options: one for importing products and assigning available GTINs, and another for importing products that already have GTINs.

Note that you cannot use the import templates to create new Unit of Use items, and GTIN-14s for higher-level packaging must be entered manually.

Please review the Product Share Article for more information. 

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