GEM Check Coag Control-Abnormal for PT

Basic Information

• Brand Name: GEM Check Coag Control-Abnormal for PT
• Primary DI: 08426950452706
• Version / Model: 06260061700
• Catalog Number: 06260061700
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2024-01-26
• Public Version Status: Update
• Public Device Record Key: f5e26838-3086-415e-8666-82e18ab024d9
• Distribution End Date: 2024-01-25

Device Description

GEM Check Coag Control-Abnormal for PT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
GGN	PLASMA, COAGULATION CONTROL	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950452706	GS1
Unit of Use	18426950452703	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K944691	000

Storage Conditions

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