i-STAT

Basic Information

• Brand Name: i-STAT
• Primary DI: 00054749001200
• Version / Model: 06P17-04
• Catalog Number: 06P17-04
• Company Name: ABBOTT POINT OF CARE INC.
• Labeler DUNS: 079226216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: fb757fc7-0e38-4f6c-999d-ae807e2e074f

Device Description

i-STAT CK-MB, Calibration Ver Set

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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44693	Creatine kinase myocardial isoenzyme (CKMB) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00054749001200	GS1
Unit of Use	10054749001207	GS1

Customer Contacts

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

Storage Conditions

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