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Reference · Device identification

UDI and GUDID Data Requirements for Catalog Teams

A unique device identifier is not one number. It is a fixed part and a variable part, and confusing them is what turns a clean catalog into a pile of near duplicate records.

Reviewed · 6 min read

The Short Answer

A UDI has two parts. The device identifier, or DI, is fixed for a given model and version, and it is the part submitted to the FDA Global Unique Device Identification Database. The production identifiers, or PIs, change from unit to unit and cover lot or batch number, serial number, expiration date, date of manufacture, and the distinct identification code for certain devices. PIs are not stored in the GUDID: the labeler records only which of them appear on the label. For a seller catalog, that split is the useful part. The DI is a stable key that belongs on the product record, and the production identifiers belong to the individual unit you are selling.

At a Glance

Who the obligation falls on
The labeler, meaning whoever puts the label on the device or causes it to be replaced
What is submitted to the GUDID
The device identifier and the record attributes that go with it
What is not submitted
Production identifier values. Only their presence on the label is flagged
Who issues identifiers
FDA accredited issuing agencies: GS1, HIBCC and ICCBBA
How records are submitted
The GUDID web interface one device at a time, or HL7 SPL files through the FDA Electronic Submissions Gateway in bulk
Where the public can read it
AccessGUDID, hosted by the National Library of Medicine

Most catalog problems that look like matching problems are identifier problems. A team stores a full UDI string scanned from a box, treats it as the product key, and then finds that the same model has produced four hundred different keys because every unit carried a different lot number. The fix is not a better matching algorithm. It is knowing which half of the identifier was supposed to be the key.

What a UDI Is Made Of

A unique device identifier appears on device labels and packages, and in some cases directly on the device itself, in both plain text and machine readable form. It is a single printed string, which is exactly why it gets treated as a single value. It is not one. It is a concatenation of two separately governed things.

One unique device identifierUDICarried on the label in plain text and in machine readable formDevice identifierDI: fixed for the modelIdentifies the labeler and the specific versionor model of the device. It does not changefrom one unit to the next.Production identifiersPI: varies by unitLot or batch numberSerial numberExpiration dateDate of manufactureDistinct identification codeSubmitted to the GUDIDNot stored in the GUDID. The labeler recordsonly which of these appear on the label.
The device identifier is the half that behaves like a catalog key. The production identifiers describe the unit in your warehouse.

The Device Identifier Is the Part That Stays Still

The DI identifies the labeler and the particular version or model of the device. Two units of the same model, made two years apart in different factories, carry the same DI. That property is what makes it valuable to a catalog: it is the closest thing the medical device world has to a durable product key that a buyer, a seller and a hospital system will all recognise.

It is issued under the system of one of the FDA accredited issuing agencies. GS1 is the most widely used and its identifier is a GTIN. HIBCC issues a Labeler Identification Code that the labeler combines with its own product or catalog number. ICCBBA covers blood, cellular therapy and tissue products. The three formats do not look alike, so a validation rule that only recognises one of them will silently reject the others.

  • One DI per model and version. A packaging change that creates a new package configuration gets its own DI.
  • The DI is the primary key in the GUDID record, and the key you can look up on AccessGUDID.
  • A DI is stable across time, so it survives a catalog migration in a way an internal SKU does not.
  • It is not a universal product key. Devices sold outside the systems that require a UDI may not carry one at all, so a catalog cannot treat it as mandatory.

Production Identifiers Belong to the Unit

The PI segment is where lot number, serial number, expiration date, manufacture date and, for certain devices, a distinct identification code live. These are properties of the physical thing on the shelf. They tell you nothing about what the model is and everything about which unit you are holding.

The Mistake That Creates a Thousand Phantom Products

If your import pipeline stores the whole scanned UDI string as the product identifier, every unit becomes a distinct product. The catalog then reports hundreds of items where there are three models. Parse the DI out and key on that; keep the PI values on the unit record where they describe something real.

What a GUDID Record Carries

The GUDID holds more than the identifier. A record carries descriptive and safety attributes that a catalog team will recognise, because they are the same attributes buyers ask about. The table below is a selection rather than the full element list, chosen for the fields that do real work in a commercial catalog.

Selected GUDID attributes and what a catalog can do with each
AttributeWhat it isCatalog use
Primary DIThe device identifier for the recordThe product key. Match imports against this before anything else.
Brand nameThe name the device is marketed underReconciles a supplier spreadsheet that lists a brand rather than a manufacturer.
Version or model numberThe manufacturer's own model designationThe human readable half of identity. Buyers search this, not the DI.
Company nameThe labelerNot always the manufacturer people name in conversation. Worth holding both.
Device descriptionThe labeler's description of the deviceA starting point for content, never a finished description.
MRI safety statusWhether the device is MR safe, conditional or unsafeA genuine buyer filter, and a claim that must never be guessed.
Contains natural rubber latexA latex statementA safety relevant attribute. Absence of a value is not a no.
Sterilization attributesWhether it is supplied sterile and the methodDrives a filter and a real purchasing decision.
FDA product codeThe FDA classification code for the device typeGroups a catalog into device types that map to regulatory categories.
Commercial distribution statusWhether it is still in commercial distributionFlags lines that are ending, which a stale catalog will keep selling.

How This Shapes a Seller Catalog

You are probably not a labeler. Most equipment sellers, refurbishers and distributors are not, so the submission obligation is not yours. What is yours is the consequence: your suppliers, your buyers and the hospital systems you sell into all key on these identifiers, and a catalog that cannot speak that language creates work for everyone downstream.

  1. Store the DI as Its Own Field

    Not concatenated with anything, not merged into the model column, and not reconstructed from a barcode scan at read time. Give it a column and a validation rule per issuing agency format.

  2. Keep the Model Number Beside It

    The DI is what machines match on. The version or model number is what a person types into a search box. A catalog needs both, and needs to know which is which.

  3. Put Production Identifiers on the Unit Record

    Serial number, lot and expiry describe a specific unit. If your data model has nowhere to put them, that is the gap to close before you start writing content.

  4. Treat an Absent Attribute as Absent

    A GUDID record with no latex statement is not a record that says there is no latex. Empty is not a value, and a catalog that renders empty as no is publishing a safety claim nobody made.

Where Teams Get This Wrong

  • Treating the scanned string as the product key, which multiplies one model into hundreds of records.
  • Assuming every device has a UDI. Older inventory, devices outside the requirement, and equipment sold in markets that do not require one will not have one.
  • Assuming the labeler is the manufacturer. They are often the same company and sometimes not, and a catalog that conflates them will attribute a device to the wrong brand.
  • Copying the GUDID device description straight into a product page. It is a regulatory description written for a database, not copy written for a buyer, and it is thin enough to look like a placeholder.
  • Rendering a blank attribute as a negative statement. This is the single most consequential formatting decision on this list.

What GearDock Does With This

GearDock resolves each imported row to a device before it writes anything, and identifier fields are the strongest signal it has for doing that. Rows it cannot resolve confidently are grouped into an exception queue rather than guessed at. Attributes it cannot support from an attached document are reported as gaps and left out of the draft, which is why a blank latex field stays blank instead of becoming a sentence.

One Thing This Page Is Not

This page explains how a rule is written and what it means for catalog data. It is not legal or regulatory advice, and it does not describe your specific obligations. Confirm those with your own regulatory counsel before acting on them.

Questions

What People Ask About This

Is the device identifier the same as a GTIN?

It is when the identifier was issued under the GS1 system, which is the most common case. A GTIN is then the DI portion of the UDI. Identifiers issued by HIBCC or ICCBBA are not GTINs and have their own formats, so a catalog field that only validates GTIN structure will reject legitimate identifiers.

Does the GUDID store serial numbers and lot numbers?

No. Production identifier values, including serial number, lot or batch number, expiration date and date of manufacture, are not submitted to the GUDID. The labeler indicates which production identifiers appear on the device label, but the values themselves are not held in the database.

Who has to submit data to the GUDID?

The labeler, which the rule defines as the person who causes a device to be labelled with a view to commercial distribution, or who causes the label to be replaced or modified. A reseller that does not relabel a device is generally not the labeler for that device, though it still has to handle the identifiers correctly in its own systems.

Can I use AccessGUDID data in my product catalog?

AccessGUDID publishes GUDID content and provides search, download and web service access through the National Library of Medicine. Whether a given use fits your commercial arrangements and the terms attached to the data is a question for your own counsel. Treat it as a reference to check identity against rather than a source of finished marketing copy.

What happens if two suppliers give me the same model under different identifiers?

Look at whether the identifiers differ because the packaging configuration differs, which is a legitimate reason for a separate DI, or because one supplier gave you an internal code. The first is two real records. The second is one record with a bad field, and merging them without checking will lose the packaging distinction a buyer needs.

Sources

Where This Comes From

Regulatory statements on this page trace to the documents below. They are the authority; this page is a reading of them for catalog teams.

Private Beta

Bring This into Your Own Catalog

GearDock resolves what each product is, writes from the documents you attach, and holds back anything they do not support. A pilot runs it on your catalog with us present.