AccessGUDID - DEVICE: i-STAT G3+ Cartridge (00054749005673)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT G3+ Cartridge
Version or Model: 03P78-26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03P78-26
Company Name: Abbott Point of Care Inc.

Primary DI Number: 00054749005673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 116279183 *Terms of Use

Device Description: For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52861	Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223857	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b09a94b8-e1af-4b7b-a949-0869adcde4a7
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023