i-STAT

Basic Information

• Brand Name: i-STAT
• Primary DI: 10054749001986
• Version / Model: 06P23-25
• Catalog Number: 06P23-25
• 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: 3
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: bfbc6b4e-86df-4d61-b1a7-30e324cf0c4e
• Distribution End Date: 2019-12-31

Device Description

CARTRIDGE, cTnI

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
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	10054749001986	GS1
Package	00054749001989	GS1	Case	25	Not in Commercial Distribution	2019-12-31

Customer Contacts

• Phone: [phone]
• 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