Coatest Heparin

Basic Information

• Brand Name: Coatest Heparin
• Primary DI: 08426950088196
• Version / Model: 25 5539 63
• Catalog Number: 25 5539 63
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: 23b502af-4621-4c70-a6db-6cbf64746577

Device Description

Coatest Heparin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
KFF	ASSAY, HEPARIN	Hematology	864.7525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56195	Heparin anti-Xa IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950088196	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K833891	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: When kept at 2-8°C the sealed reagents are stable until expiry date printed on the label. Avoid contamination by microorganisms in opened vials.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius