UDI device identifier

CLEARLINK 2R8401

UDI device identifier 00085412565767 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412565767
Brand name CLEARLINK
Version or model 2R8401
Catalog number 2R8401
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FPA
GMDN term Basic intravenous administration set, noninvasive
Premarket submission K112893
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Jul 11, 2017
Version date Apr 7, 2021
Description Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 76" 1.9m approx., 10 drops/mL approx.

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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