i-STAT

Basic Information

Brand Name: i-STAT
Primary DI: 10054749001917
Version / Model: 09P31-25
Catalog Number: 09P31-25
Company Name: ABBOTT POINT OF CARE INC.
Labeler DUNS: 079226216
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-09
Public Version: 5
Public Version Date: 2023-09-11
Public Version Status: Update
Public Device Record Key: 32d46465-261c-4472-9d0a-b68e2069a5f6

Device Description

CARTRIDGE, CHEM8+

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: No
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
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
59249	Sodium (Na+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen.	No	Active
59240	Chloride (Cl-) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of chloride (Cl-) ions in a clinical specimen.	No	Active
53590	Urea 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 qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.	No	Active
59248	Potassium (K+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.	No	Active
30205	Creatinine/ammonium electrode IVD	An electrochemical sensor in which an interaction between one or more immobilized enzymes (e.g., creatinine iminohydrolase) and creatinine occurs, developing an electrical potential or current proportional to the quantity of ammonium (NH4+) resulting from the reaction. The electrode may use one of several technologies (e.g., enzyme immobilized by adsorption) and mechanisms (e.g., diffusion of ammonium). It is used to measure creatinine in body fluids (e.g., urine).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10054749001917	GS1
Package	00054749001910	GS1	Case	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053110	000

Storage Conditions

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