BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

i-STAT

DI: 10054749002280 · Model: 03P78-50 · ABBOTT POINT OF CARE INC.

View on AccessGUDID

Product Codes

1

GMDN Terms

2

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: i-STAT
Primary DI: 10054749002280
Version / Model: 03P78-50
Catalog Number: 03P78-50
Company Name: ABBOTT POINT OF CARE INC.
Labeler DUNS: 079226216
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-09
Public Version: 4
Public Version Date: 2023-09-11
Public Version Status: Update
Public Device Record Key: 727f20cc-495d-4f7c-bd33-cd807d54a879
Distribution End Date: 2023-08-31

Device Description

CARTRIDGE, G3+

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	No	Active
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10054749002280	GS1
Package	00054749002283	GS1	Case	25	Not in Commercial Distribution	2023-08-31

Customer Contacts

Phone: +1(800)366-8020
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 2 – 8 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: 2 – 8 Degrees Celsius