i-STAT

Basic Information

• Brand Name: i-STAT
• Primary DI: 00054749001262
• Version / Model: 04J48-20
• Catalog Number: 04J48-20
• 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: 2016-09-22
• Public Version: 6
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 71119179-c8c6-498f-b62a-7657c0d2972b

Device Description

MILITARY KIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62181	Multiple clinical chemistry analyser IVD, point-of-care	A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00054749001262	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001387	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 46 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: High: 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: High: 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 16 – 30 Degrees Celsius