UDI device identifier

i-STAT 04P75-01R

UDI device identifier 00054749003600 · ABBOTT POINT OF CARE INC.

Key facts

Primary DI 00054749003600
Brand name i-STAT
Version or model 04P75-01R
Catalog number 04P75-01R
Company ABBOTT POINT OF CARE INC.
DUNS number 079226216
Product code CGA
GMDN term Multiple clinical chemistry analyser IVD, point-of-care
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Sep 9, 2016
Version date Oct 18, 2023
Description i-STAT 1 Analyzer, Immuno Ready

At a glance

  • 1–9 MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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