UDI device identifier

CLEARLINK/CONTINU-FLO 2R8454

UDI device identifier 00085412565644 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412565644
Brand name CLEARLINK/CONTINU-FLO
Version or model 2R8454
Catalog number 2R8454
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FMG
GMDN term Intravenous line stopcock
Premarket submission K130245
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Jul 11, 2017
Version date Jul 6, 2018
Description Non-DEHP CONTINU-FLO Solution Set, 68" 1.7m approx., 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Non-DEHP Large Bore Stopcock Extension Set, 59" 1.5m, 8.7 mL approx., Large Bore Stopcock Manifold, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 10…

At a glance

  • None 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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