UDI device identifier

Extension Set 5C4464P

UDI device identifier 00085412030555 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412030555
Brand name Extension Set
Version or model 5C4464P
Catalog number 5C4464P
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FKX
GMDN term Peritoneal dialysis system tubing set
Premarket submission K833065
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 24, 2015
Version date Jul 21, 2023
Description This device is indicated for use in the treatment of patients with renal failure to provide extended length to the drain line of the Baxter Automated PD Disposable Sets.

At a glance

  • 1–9 MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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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