UDI device identifier

CLEARLINK 2N8378

UDI device identifier 00085412048918 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412048918
Brand name CLEARLINK
Version or model 2N8378
Catalog number 2N8378
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FPA
GMDN term Intravenous administration tubing extension set
Premarket submission K112893
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 24, 2016
Version date Jul 6, 2018
Description Non-DEHP Catheter Extension Set, Luer Activated Valve for IV Access, Male Luer Lock Adapter with Retractable Collar

At a glance

  • 10–99 MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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