GEM critCheck

Basic Information

• Brand Name: GEM critCheck
• Primary DI: 08426950452058
• Version / Model: 0002309
• Catalog Number: 0002309
• 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: 5
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: b13802c6-e206-472b-80c2-64122d1ab537

Device Description

GEM critCheck

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
GLK	CONTROL, HEMATOCRIT	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55867	Red blood cell count IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950452058	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 28 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store unopened ampules at room temperature (20-28°C). Ampules must be at (20-28°C) prior to and during use. DO NOT FREEZE.