Written and maintained by CASRAI Editorial Board
Last updated
Medical inventory tracking is the practice of recording which medical or laboratory items you hold, what exactly each one is, and the label data that decides whether it can still be used. For device-type supplies, two pieces of that data come from the label: the device identifier (model-level, in a public FDA database) and the production identifier (lot, serial, expiration; printed on the label only). This page is general product and regulatory information, not medical or legal advice.
Short answer
A tracking record needs both layers. The device identifier (DI) tells you what the item is and can be looked up in the FDA-supported GUDID database. The production identifier (PI), which carries lot or batch, serial number and expiration or manufacture date, is not stored in GUDID, so it has to come from the label or its scan. Storage conditions and expiration dates then matter for use: for laboratories under CLIA, 42 CFR 493.1252 requires them to be defined, labeled and respected.
What medical inventory tracking covers
This page is about consumables and supplies: gloves, reagents, test kits, syringes and similar items that are received, stored, used and replaced. Durable equipment follows a different record, with asset tags, service history and replacement planning; that is covered in biomedical equipment inventory tracking, tagging and lifecycle. Counting methods and reorder rules are separate topics, for example cycle counting and par levels; software choices are compared in laboratory inventory management software. The question here is narrower: which data identifies an item, and which of it can be captured automatically.
What a UDI lets you capture: device identifier versus production identifier
FDA describes a Unique Device Identification (UDI) as a unique numeric or alphanumeric code with generally two components (FDA, UDI Basics, checked 2026-11-01):
- Device identifier (DI): a mandatory, fixed portion that identifies the labeler and the specific version or model of a device.
- Production identifier (PI): a conditional, variable portion that identifies one or more of the lot or batch, serial number, expiration date and manufacture date.
A UDI appears in two forms on the label: easily readable plain text, and a machine-readable form using automatic identification and data capture (AIDC). Under 21 CFR 801.3, AIDC means any technology that conveys the UDI in a form that can be entered into an electronic patient record or other computer system by an automated process. In practice that is what a barcode scan does; the symbologies themselves are explained in GS1-128 barcodes and Data Matrix versus QR code. The full UDI system is covered in UDI for medical devices.
The same regulation defines a lot or batch as one or more finished devices of a single type, model, class, size and composition manufactured under essentially the same conditions. That definition is why a lot number is the unit you act on in a recall or an expiry check; see lot number for the identifier itself.
Where each piece of data lives
AccessGUDID, the public database from the National Library of Medicine, holds device identification information submitted to FDA. Its own description says it contains only the device identifier: production identifiers are not submitted to or stored in GUDID, although GUDID data indicates which PIs appear on the device label (AccessGUDID About, checked 2026-11-01). It also collects no information on patients or users.
The consequence for an inventory record is practical. Looking up a DI returns model-level data, but it cannot tell you the lot, the serial number or the expiration date of the box on your shelf. Those values exist only on the label, so a system that is meant to act on them has to capture the PI from the scan or from keyed entry. Also note that UDIs were phased in starting with the highest-risk devices, so only part of the devices in use have GUDID records; a missing record is not by itself an error.
Laboratory storage and expiry rules (CLIA)
For laboratories performing testing under the Clinical Laboratory Improvement Amendments, 42 CFR 493.1252 sets rules that map directly onto inventory fields (Cornell LII text, checked 2026-11-01):
- Paragraph (b): the laboratory must define the storage conditions essential for reagents and specimens, and those conditions must be monitored and documented.
- Paragraph (c): reagents, solutions, control materials and supplies must be labeled with their storage requirements and their preparation and expiration dates.
- Paragraph (d): reagents, solutions, control materials and supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality.
These obligations apply to CLIA-regulated laboratory testing. They do not describe what every clinic, school or storeroom must do, and other settings are governed by their own rules.
Fields to record per item
Each field below is tied to a stated function in one of the cited sources.
| Field | Where the value comes from | Why a source says it matters |
|---|---|---|
| Device identifier (DI) | Label, plain text or scan; model-level lookup in AccessGUDID | Identifies the labeler and the version or model (FDA UDI Basics) |
| Lot or batch | Label (PI); not stored in GUDID | Groups finished devices made under essentially the same conditions (21 CFR 801.3) |
| Serial number | Label (PI), where the item carries one | Part of the conditional PI (FDA UDI Basics) |
| Expiration date | Label (PI) or the lab’s own labeling of prepared materials | Items past expiry must not be used in CLIA testing (42 CFR 493.1252(c), (d)) |
| Manufacture date | Label (PI), where present | Part of the conditional PI (FDA UDI Basics) |
| Storage condition | Defined by the laboratory for reagents and specimens | Must be defined, monitored and documented (42 CFR 493.1252(b)) |
| Status (usable or not) | Your own record, driven by the expiry and quality fields | Expired, deteriorated or substandard items must not be used (42 CFR 493.1252(d)) |
Common misunderstandings
Scanning a UDI gives me the lot and expiry from the FDA database
It does not. GUDID holds the DI only. The lot and expiry travel in the PI on the label, so they are read from the scan itself.
Equipment tracking and supply tracking are the same record
They are not. Equipment is tracked as individual assets over years; consumables are tracked by item, lot and expiry. The two meet where a device carries a UDI, which the equipment guide covers.
Every item in stock will have a UDI
Not necessarily. UDI requirements were phased in by device risk, and many laboratory reagents and chemicals sit outside the device system. Expect to key in some records by hand.
Frequently asked questions
What is the difference between a DI and a PI?
The DI is the fixed part of a UDI that identifies the labeler and the device version or model. The PI is the variable part that carries lot or batch, serial number, expiration date and manufacture date (FDA, UDI Basics).
Does GUDID list lot numbers or expiration dates?
No. AccessGUDID states that it contains only the device identifier; production identifiers are not submitted to or stored in it.
Do CLIA expiry and storage rules apply to every medical inventory?
No. 42 CFR 493.1252 applies to laboratories performing CLIA-regulated testing. Other settings follow the rules that govern them.
Can a barcode scan feed an inventory system directly?
That is what AIDC means in 21 CFR 801.3: a technology that conveys the UDI in a form that can be entered into a computer system by an automated process.
Sources
- FDA, UDI Basics, checked 2026-11-01.
- 21 CFR 801.3, definitions (Cornell LII), checked 2026-11-01.
- National Library of Medicine, AccessGUDID: About GUDID, checked 2026-11-01.
- 42 CFR 493.1252, test systems, equipment, instruments, reagents, materials and supplies (Cornell LII), checked 2026-11-01.
