Lot and serial traceability links every device unit to where it came from and where it went. We capture UDI data at receiving, verify it at pick and pack, and keep shipment records that show which lots and serials reached which consignee.
How UDI data flows through fulfillment
A Unique Device Identifier has two parts. The device identifier (DI) is static and identifies the labeler and the specific version or model. The production identifier (PI) is variable and can include the lot or batch number, serial number, expiration date and manufacturing date. FDA's UDI rule requires labelers to place the UDI on device labels and packages in both human-readable and machine-readable form, and to submit DI records to the Global Unique Device Identification Database (GUDID).
In fulfillment, the machine-readable PI is what matters most. GS1 barcodes encode it with application identifiers such as (01) for the GTIN, (10) for lot, (17) for expiration date and (21) for serial number. We parse those barcodes at receiving and again at picking, so the data in the system comes from the label itself rather than from manual keying.
Scan-verified picking and packing
Traceability fails most often at the pick face, when a picker grabs the right SKU from the wrong lot. Our workflow directs the picker to a specific location and lot, then requires a scan of the unit or inner pack to confirm it. A mismatch stops the pick before the item reaches a carton.
Serialized devices are scanned individually at pack-out, and the serial numbers are written to the shipment record. For lot-controlled items shipped in inner packs or cases, the lot is captured at the level the product is packaged, so the record reflects reality. The packing list can print lot, serial and expiry details where your customers or contracts require them, which many hospital receiving teams do.
Consignee-level distribution records
Manufacturers are expected to know where their devices went. For a recall, a correction or a field safety notice, the question is always the same: which consignees received the affected lots or serials, how many units, and when. If your 3PL can only answer by SKU, you end up notifying every customer you have.
We keep shipment records at the consignee level, including ship-to name and address, order and PO numbers, carrier and tracking, ship date, and the lot and serial detail of every line. Those records are queryable on demand by lot, serial, item, date range or customer, and can be exported in formats your regulatory or quality team uses for effectiveness checks.
Audit trails and record retention
Every inventory event is logged with a user, a timestamp and a reason: receipts, putaways, moves, holds, releases, adjustments, picks and shipments. That audit trail lets your quality team reconstruct the history of any unit during an internal audit, a supplier audit or an FDA inspection of your own establishment.
Record retention periods for medical device distribution records are set by your quality system, and device regulations generally tie them to the design and expected life of the device, so the retention period belongs in your quality agreement. We agree on retention, export formats and how records are transferred if the relationship ends, so your data never becomes stranded in a former provider's system.
What's included
- GS1 and HIBCC barcode parsing (DI and PI)
- Directed, scan-confirmed lot picking
- Serial capture at pack-out
- Lot, serial and expiry on packing lists where required
- Consignee-level shipment history by lot or serial
- Full user and timestamp audit trail
- Agreed record retention and export formats
Frequently asked questions
What is lot and serial traceability for medical devices?
Lot and serial traceability is the ability to link every device unit to its production lot or serial number and to the consignee that received it, so affected units can be located quickly in a recall or investigation.
Do you read UDI barcodes?
Yes. We parse GS1 and HIBCC UDI barcodes to capture the device identifier and production identifiers such as lot, serial number and expiration date directly from the label.
Can you track serial numbers on every outbound unit?
Yes. Serialized devices are scanned at pack-out and each serial number is stored on the shipment record with the consignee, order and ship date.
Who is responsible for GUDID submissions?
The labeler, typically the manufacturer, is responsible for UDI labeling and GUDID submissions. A 3PL captures and uses the UDI data on the label but does not submit to GUDID on your behalf.