GUDIDGlobal Unique Device Identification Database

GUDID — the Global Unique Device Identification Database — is the publicly searchable FDA database that holds the device-identifier (UDI-DI) portion of every Unique Device Identifier assigned to a medical device commercially distributed in the United States. It is the data-side of the UDI rule: the label on the device carries the UDI; GUDID carries the structured attributes (brand name, model, sterility, MRI compatibility, single-use status, contains latex, FDA premarket submission number, GMDN code, and ~50 other fields) that make that label meaningful at the point of use.

GUDID was established by the UDI Final Rule (78 FR 58786, September 2013) implementing section 519(f) of the FD&C Act. It is administered by FDA's Center for Devices and Radiological Health (CDRH) and surfaces publicly through the AccessGUDID portal at accessgudid.nlm.nih.gov. Hospitals, payers, EHRs, recall coordinators, and FDA's own MAUDE surveillance system all pull device attributes from GUDID; an incomplete or inaccurate GUDID record means a device the healthcare system cannot fully use even if it is legally cleared.

A UDI is built from two parts. The Device Identifier (DI) is the mandatory, fixed portion identifying the labeler and the specific version or model of the device — this is the part submitted to GUDID. The Production Identifier (PI) is the conditional, variable portion identifying production-specific data — typically lot or batch number, serial number, manufacturing date, expiration date, distinct identification code for HCT/Ps. PIs are not submitted to GUDID; they accompany the DI on the label per the issuing agency's format.

Three FDA-accredited issuing agencies issue UDIs: GS1 (GS1 GTIN-based UDIs, the most common globally), HIBCC (Health Industry Business Communications Council, HIBC-based), and ICCBBA (for blood, cellular, tissue, and organ products under ISBT 128). The labeler chooses which agency to use; the DI format follows that agency's standard but the GUDID record structure is the same regardless.

FDA's GUDID Data Elements Reference Table defines every field. The required attributes for most devices include:

• Primary DI Number — the GS1, HIBCC, or ICCBBA DI string.
• Device Description — short marketing description.
• Brand Name — commercial brand under which the device is marketed.
• Version or Model Number — manufacturer's version/model designator.
• Catalog Number — manufacturer's catalogue identifier.
• Company Name — the labeler responsible for the device.
• DUNS Number — Dun & Bradstreet identifier of the labeler.
• Premarket Submission Number — the 510(k) K-number, De Novo DEN-number, PMA P-number, HDE H-number, or BLA STN-number under which the device cleared.
• Product Code — the FDA three-letter product code that classifies the device.
• GMDN Preferred Term Code — Global Medical Device Nomenclature code identifying the device type.
• Package quantity and Unit of Use DI — for devices distributed in higher-level packaging.
• Sterility attributes — Sterilization Required Prior to Use, Device Packaged as Sterile, Method of Sterilization.
• Safety attributes — MRI Safety Status, Contains Latex, Single Use, Lot/Batch tracked, Serial Number tracked, Manufacturing Date tracked, Expiration Date tracked.
• Storage and handling conditions.
• Clinical sizes (length, width, weight, volume) for devices where these are part of the model designation.

The UDI Final Rule phased compliance by device class:

All devices subject to the rule are now within their compliance window. New device clearances or new versions of cleared devices must have a GUDID record before commercial distribution begins. Discontinued devices remain in GUDID; they are flagged with a Discontinue Date and remain searchable for post-market surveillance and historical reference.

Submission is handled by the labeler — the entity that causes a label to be applied to a device. Three steps: (1) Obtain a DUNS Number from Dun & Bradstreet (free) and register the labeler in GUDID via the FDA's GUDID account request. (2) Choose an issuing agency (GS1, HIBCC, or ICCBBA) and obtain DIs for each device version/model. (3) Submit DI records to GUDID via either the Web Interface (small volume) or HL7 SPL (Structured Product Labeling) XML submissions (medium-to-large volume), or via a third-party submission service that automates SPL generation.

Once submitted, the record is reviewed and either published or returned for correction. Published records appear in AccessGUDID typically within 7 days. Maintenance is ongoing: any change to a GUDID-reportable attribute (brand name, sterility, premarket submission number after a supplement, MRI status, packaging configuration) must be updated in GUDID. The labeler must also confirm GUDID record accuracy annually via the FDA's annual recertification process.

• Mismatched premarket submission numbers — GUDID record cites K123456 but the cleared 510(k) is K123654.
• Brand name inconsistency between label artwork, IFU, GUDID record, and FDA 510(k) submission.
• Wrong issuing agency — submitting a HIBCC-formatted DI as a GS1 record (or vice versa) — the DI string format check fails and the record is rejected.
• Sterility attributes inconsistent with label claims — label says 'sterile' but GUDID says 'Sterilization Required Prior to Use'.
• MRI Safety Status set to 'Labeling does not contain MRI Safety Information' when the IFU does contain it — usability and recall implications downstream.
• Higher-level packaging DI omitted — the Unit of Use DI is registered but the case and pallet DIs are not, so distributor scanning systems cannot link receipts back to the unit DI.
• Discontinue Date not updated when a SKU is end-of-lifed, leaving an active record for a non-distributed device.
• Annual recertification missed — GUDID record flagged as unverified, which downstream systems may treat as 'do not use'.