Medical Device Fulfillment Glossary

510(k): A premarket notification submitted to the FDA to show that a device is substantially equivalent to a legally marketed predicate device. Many Class II devices reach market this way.
Advance ship notice (ASN): An electronic notice, often EDI 856, sent before a shipment arrives that lists its contents, packaging and identifiers such as SSCC, lot and quantity.
CAPA: Corrective and preventive action, a structured process for investigating the cause of a problem and taking action to correct it and prevent recurrence.
Complaint: Any communication alleging deficiencies in a device's identity, quality, durability, reliability, safety, effectiveness or performance after release. Complaints must be documented and evaluated.
Consignee: The party that receives a shipment. In a recall, consignee lists show who received affected product so they can be notified.
Controlled room temperature: A labeled storage condition for products that must be kept within a defined room-temperature range, rather than unmonitored ambient conditions. The exact range comes from the product labeling.
Correction or removal: Under 21 CFR Part 806, actions taken to repair, adjust, relabel or inspect a device in place, or to physically remove it from where it is used or sold. Certain corrections and removals must be reported to the FDA.
Device classification: The FDA's risk-based Class I, II and III system for medical devices. Class determines the regulatory controls and premarket pathway that apply.
Device Identifier (DI): The fixed portion of a UDI that identifies the labeler and the specific version or model of a device. In GS1 systems it is typically a GTIN.
Disposition: The documented decision about what happens to held or nonconforming product, such as release, rework, return to supplier or destruction.
Durable medical equipment (DME): Reusable medical equipment such as walkers, hospital beds and some monitoring devices, prescribed for use in the home. DME is a distinct category for payer and supplier rules.
Establishment registration: Annual registration with the FDA required for facilities that perform certain device activities, such as manufacturing, relabeling, repackaging or initial importing. Storage and distribution of finished devices alone generally do not require it.
FEFO: First expired, first out, an allocation rule that ships the stock with the earliest expiration date first. It reduces expired inventory and supports minimum shelf-life commitments.
GS1-128: A barcode symbology that encodes data with application identifiers, such as GTIN, lot, expiry and serial. It is common on device case labels and on pallet labels as a serial shipping container code.
GTIN: Global Trade Item Number, a GS1 identifier for a trade item. Many device labelers use a GTIN as the device identifier portion of the UDI.
GUDID: The FDA's Global Unique Device Identification Database, which holds key device identification information submitted by labelers. It stores DI-level data, not production identifiers.
ISO 13485: The international standard for quality management systems for medical devices. It covers design, production, storage, distribution and service activities, including control of suppliers.
Lot or batch number: An identifier assigned to a quantity of devices produced under the same conditions. Lot control lets a company locate every unit from a production run if a problem is found.
Medical Device Reporting (MDR): The FDA reporting requirements in 21 CFR Part 803 for certain deaths, serious injuries and malfunctions associated with devices. Complaint evaluation determines whether a report is required.
Minimum remaining shelf life: The shortest acceptable time between ship date and expiration date for a given customer or channel. Hospitals, distributors and marketplaces often set their own minimums.
Mock recall: A practice exercise that traces a selected lot or serial number to every consignee and verifies records and response times, without an actual product problem.
Nonconforming product: Product that does not meet specified requirements. It must be identified, documented, segregated and dispositioned under the quality system.
Production Identifier (PI): The variable portion of a UDI that can include lot or batch number, serial number, expiration date, manufacturing date and, for some products, a distinct identification code.
QMSR: The FDA's Quality Management System Regulation in 21 CFR Part 820, which incorporates ISO 13485:2016 by reference. It replaced the earlier Quality System Regulation framework with an effective date in February 2026.
Quality agreement: A written agreement that defines quality responsibilities between a device company and a supplier such as a 3PL, including holds, complaints, deviations, records and change control.
Quarantine: A controlled status and segregated location for product that cannot be shipped pending review, such as damaged receipts, returns or suspect lots. Release requires a documented disposition.
Serialization: Assigning a unique serial number to each individual unit so it can be tracked one by one. Common for capital equipment, powered devices and implantables.
SSCC: Serial Shipping Container Code, an 18-digit GS1 identifier for a logistics unit such as a pallet or case. It links the physical shipment to the advance ship notice.
Sterile barrier system: The minimum packaging that prevents microbial entry and allows aseptic presentation of a sterile device. Its integrity must be protected through storage and shipping.
Unique Device Identifier (UDI): A unique numeric or alphanumeric code on a device label that identifies the device through distribution and use. It consists of a device identifier and, where applicable, a production identifier.

Medical Device fulfillment glossary