Medical and lab supply integrations: UDI data, lots and expiry, and the right buyer for each product

What medical and lab suppliers run into

• Who may buy. Prescription devices go only to licensed practitioners and the distribution chain. A store that shows every product to every login sells to the wrong buyer.
• Every unit has a UDI. The label carries a device identifier and, depending on the device, a lot, a serial, an expiration date or a manufacturing date. Recalls and returns are traced on those.
• Expiry by lot. Sterile and reagent products expire, and a hospital can refuse stock with less than its minimum shelf life left.
• Product data with regulatory flags. Latex, sterile, MRI safety and storage temperature are facts with a source, not marketing copy.
• Lab shipments. Chemicals need a safety data sheet; frozen samples and reagents go out on dry ice, which is a hazardous material by air.

The flows that matter most

Device data from GUDID

The FDA's UDI rule makes the labeler, typically the manufacturer, put a UDI on labels and packages and submit the device to the Global Unique Device Identification Database. A UDI has two parts under 21 CFR 830.3: the device identifier, fixed per model and labeler, and the production identifier, which is the lot, serial, expiration date or manufacturing date that the label carries. Three issuing agencies are accredited by FDA: GS1, HIBCC and ICCBBA.

AccessGUDID publishes every record through a public API: GET /api/v3/devices/lookup.json?di=... returns the device, and parse_udi.json splits a full UDI into its parts. For a distributor this is a product data source that the manufacturer keeps current.

The flags lotBatch, serialNumber, expirationDate and manufacturingDate say which production identifiers appear on the label. The integration turns them into picking rules: a device with lotBatch true cannot be packed without a lot scan. rx and otc decide the catalog. When deviceCommDistributionStatus changes, the product is hidden instead of staying on sale after the manufacturer stopped distributing it.

The same date in two formats

A GS1 UDI writes the expiry as YYMMDD after application identifier 17. An ICCBBA UDI can write it as YYYJJJ, a year and a day number. AccessGUDID's own example shows 014032 as February 1, 2014: day 32 is January's 31 days plus one. For a device expiring on March 31, 2027:

GS1     (01)00614141209811(17)270331(10)K2291
ICCBBA  expiry 027090 = 2027, day 31 + 28 + 31 = 90 = March 31

The integration stores both as 2027-03-31, the YYYY-MM-DD format FDA requires for dates on device labels, and compares expiry in that form. A parser that reads 027090 as a YYMMDD date finds month 70 and rejects the line, so the format is taken from the issuing agency of each UDI, which parse_udi returns as issuingAgency.

Lots, expiry and serials through the order

Stock in the store is the sum of sellable lots. A hospital account with a rule of, for example, at least 12 months of remaining shelf life at shipping sees only the lots that meet it; a clinic without the rule sees all of them. The arithmetic is the same as for any stock that counts, with expiry as one more filter.

At picking, the scan of the UDI fills the production identifiers on the fulfillment line. In NetSuite that is the inventory detail of the line, with issueinventorynumber for the lot or serial and expirationdate. A recall of lot K2291 then becomes a query:

220 units of the lot reached 2 accounts in 3 shipments. Without lot capture the same recall goes to every account that bought the item in that period.

For devices FDA designates as tracked under 21 CFR 821, a distributor has to give the manufacturer the UDI or lot or serial, the date received and the source on receipt, and a final distributor also reports the patient-side details on sale. Those are the same fields, sent to one more party.

Who may buy what

21 CFR 801.109 exempts a prescription device from the adequate-directions rule when it is held by the distribution chain or a licensed practitioner and sold only to or on the order of such a practitioner, with "Rx only" on the label. In the store that becomes a catalog question. On Shopify, catalogs are assigned per company location: 3 active catalogs in total below Plus, up to 25 per location and 10,000 per store on Plus. A supplier with an open catalog and an Rx catalog needs 2; the account's license status in the ERP decides which locations get the Rx catalog. A license that expires moves the location back to the open catalog on the next run, with the change in that run's diff.

Lab supply: SDS and dry ice

Lab chemicals fall under OSHA's Hazard Communication standard: a distributor sends the safety data sheet with the first shipment to a customer and with the first shipment after the sheet is revised. How the integration tracks which revision each customer received is on industrial and MRO supply.

Dry ice is UN 1845, class 9. By air, 49 CFR 173.217 requires the net mass of dry ice marked on each package and documentation with the number of packages and the dry ice in each. Up to 2.5 kg (5.5 lb) per package used as a refrigerant is excepted from the other requirements when the package is marked with "Dry ice", the contents and the net weight. A shipment of 4 boxes at 2.0 kg each is 8.0 kg of dry ice on 4 packages, each under the 2.5 kg limit; a box at 3.0 kg is not. The packing station records the weight per box, and the integration puts it on the label data and the shipping record.

Systems in medical and lab supply

The EDI side, with the 850 in and the 856 with lot and expiry out, is on EDI integration. Expiry dates compared across time zones are on dates and time zones.

What this means for your integration

We build the integration on your ERP, your WMS and your store, with your rules: which products are Rx-only, which accounts hold a license, which lots each customer may receive, how a UDI is scanned at packing. Then we host and run it. Each run has a log and a diff, a fulfillment line without a required lot or expiry waits in a queue with the reason, and the shipped-lot records are there when a recall comes in.

All flows are on ecommerce ERP integration, and the related industries are food and beverage and industrial and MRO supply. The full list is under industries. Tell us which ERP and which buyers you work with, and you hear which of these flows saves the most work for you.