i-STAT

Basic Information

• Brand Name: i-STAT
• Primary DI: 10054749000125
• Version / Model: 03P84-25
• Catalog Number: 03P84-25
• 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: 4
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 62fff855-b4aa-4371-b1cf-9f5e95fa7bc0

Device Description

CREATININE CARTRIDGE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	Clinical Chemistry	862.1225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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	10054749000125	GS1
Package	00054749000128	GS1	Case	25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K973292	000

Storage Conditions

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