Attribute: Device Identifiers

A Device Identifier is a value issued by GS1 (GTIN) and HIBC (HIBCC) for inventory management and to support clinical documentation with an increased ability to scan items.

Data Sources

The source for Device Identifiers is from multiple sources, such as:

Manufacturer catalogs
FDA's AccessGUDID
Global Data Synchronization Network (GDSN)
Distributors for white labeled products

Standardization

Device identifiers are reliant on the accuracy of FDA's AccessGUDID-submitted data.

GUDID captures multiple device standards: GTIN (GS1), ICCBBA, HIBCC.

FDA requires that manufacturers submit all UDI information to the GUDID, unless an exception is mentioned otherwise. While GUDID has field-based requirements, they are highly open to interpretation by each submitting organization (e.g. catalog number). There is no audit process in place to validate the accuracy and reliability of said data (e.g. implantable flag, latex, etc).

GTIN and HIBCC codes are broken down as follows:

GHX provides Unit of Measure (UOM) because UOM is not a required field to submit to GUDID. GHX generates the Unit of Measure based on certain data assumptions (i.e. Device Count of 1 = Each).

Considerations

Device Identifiers

GHX recommends up to five Device Identifiers/UOMs per product.

Data comparisons are made depending on how the customer manages Device Identifiers in the ERP for their business processes.

This view will display the item recommendations for the scope of approval – Device Identifiers. (GTIN)

This view will display a single list of Device Identifier recommendations grouped by Buyer Part # and GHX Manufacturer Part #.

Recommendation Management

GHX can work with your organization to set your integration configuration to manage device identifiers for your specific business needs.

In Recommendation Management providers’ administration users can: