GEM Hematocrit Evaluator 3

Basic Information

• Brand Name: GEM Hematocrit Evaluator 3
• Primary DI: 08426950573685
• Version / Model: 00025000106
• Catalog Number: 00025000106
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 4a68a93b-5dad-497b-83ff-5fa3a421f8fa

Device Description

GEM Hematocrit Evaluator 3

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
GLK	CONTROL, HEMATOCRIT	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55868	Red blood cell count 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 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	08426950573685	GS1
Unit of Use	18426950573682	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.