UDI device identifier

ONE-LINK 7N8330K

UDI device identifier 00085412613499 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412613499
Brand name ONE-LINK
Version or model 7N8330K
Catalog number 7N8330K
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FPA
GMDN term Intravenous administration tubing extension set
Premarket submission K132734
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date May 22, 2018
Version date Oct 19, 2022
Description One-Link Non-DEHP 3 Lead Microbore Catheter Extension Set Bonded Needle-free IV Connector with Neutral Fluid Displacement

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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