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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.

In your GS1 US® account, 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). 

When You Have a GS1 Company Prefix

If you licensed a GS1 Company Prefix, create the primary device by following the steps in Create a Product article.

  • Select Regulated Healthcare as the industry to ensure proper classification.
  • Assign a Global Trade Item Number (GTIN) to the primary device. The primary device is the lowest packaging level that carries the identifier. 

When You Have a GS1 US GTIN

If you licensed a GS1 US GTIN, you submitted primary device details and received your GTIN during checkout. To edit product details or access your barcode image, refer to the Work with My GS1 US GTIN article.

If you are unsure whether your product is considered a Regulated Healthcare Trade Item, consult your internal regulatory or compliance team.

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 Management section of your GS1 US account.

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, you must have the General User Administrator role for your company. Navigate to Data Management under the Manage Account 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 your GS1 US account, 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 your GS1 US account. 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: You cannot use the import templates to create new Unit of Use items, and GTIN-14s for higher-level packaging must be entered manually.

GS1 US does not provide GS1‑128 barcode images.

To obtain a GS1‑128 barcode image, you’ll need to work with a GS1 US Solution Partner. Solution partners can be found by accessing the GS1 US Solution Partner Finder tool. 

 

Please review the Product Share Article for more information. 

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