What a UDI is, and what you actually have to do about it.
Most writing about Unique Device Identification is aimed at large manufacturers filing to FDA's GUDID database. This is for the smaller manufacturer or direct-to-consumer brand who has been told to start capturing UDI and wants to know what to buy and what changes at the packing station.
A UDI is two things stuck together.
The device identifier
Says what the product is: the model, from a particular labeler. It is the same on every unit of that product. In practice it is usually a GTIN issued through GS1.
The production identifiers
Say which one. A serial number for a serialized device, or a lot number and expiry date for a lot-controlled one. Sometimes a manufacture date as well.
The UDI has to appear on the label in two forms: plain text a person can read, and a barcode. The barcode is almost always a GS1 DataMatrix, the small square of dots, because it holds a lot of characters in a small space. Devices that are reused and reprocessed between patients also have to be marked on the device itself.
Identifiers come from an agency FDA has approved. GS1 is the one most people use. HIBCC and ICCBBA also run approved systems.
What scanner do I need for UDI?
This is the first practical question, and the answer is cheaper than people expect.
A 2D imager, not a laser
The laser scanner that reads the barcode on a packing slip cannot read a DataMatrix. A laser sweeps a line, and a DataMatrix is a grid. A 2D imager takes a picture and decodes it, and it reads your old 1D barcodes too. A USB one plugs in and acts like a keyboard, which is all SerialTrack needs.
Turn on the group separator
A GS1 DataMatrix uses an invisible separator character between fields that have no fixed length. Most scanners send it by default. Some need it turned on. Without it, the lot and serial run together and no software can tell where one ends.
Who has to do what.
There are two separate jobs here, and they often fall to different people. A small company selling direct usually does both.
If you label the device
You are the labeler. You get identifiers from GS1 or another approved agency, print them on the label in both forms, and submit the device identifier and its details to FDA's GUDID database. That is a labeling and data-entry project, done once per product.
If you ship the device
You need the record: which unit went to which customer, and when. That is a scanning habit at the packing station, done on every order. It is what an auditor asks to see when a recall or a complaint comes in.
A small manufacturer selling direct does both. That is why the second one so often shows up as an audit finding after the first was handled.
The regulations, with citations → · How SerialTrack captures it →
Working out what to buy?
We keep a page on the 2D imagers customers use for UDI, what they cost, and the one setting that has to be turned on before any of it works.
Scanners for UDI codesStart recording on the next shipment.
Connect your store, scan one order, and look at the record. About five minutes to set up, and nothing to pay for thirty days.