UDI device identifier

i-STAT G3+ Cartridge 03P78-26

UDI device identifier 00054749005673 · Abbott Point of Care Inc.

Key facts

Primary DI 00054749005673
Brand name i-STAT G3+ Cartridge
Version or model 03P78-26
Catalog number 03P78-26
Company Abbott Point of Care Inc.
DUNS number 116279183
Product code CHL
GMDN term Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Premarket submission K223857
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Dec 18, 2023
Version date Dec 26, 2023
Description For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2

At a glance

  • None MAUDE reports citing this UDI
  • Yes 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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