i-STAT

Basic Information

• Brand Name: i-STAT
• Primary DI: 10054749000187
• Version / Model: 03P90-25
• Catalog Number: 03P90-25
• 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: 3
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 26096d4f-7a43-4338-90ee-5fe7b9d3a3d8

Device Description

TROPONIN 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
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54013	Troponin I 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 troponin I in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10054749000187	GS1
Package	00054749000180	GS1	Case	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031739	000

Storage Conditions

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