ChemSTAT Hematocrit Evaluator 1

Basic Information

• Brand Name: ChemSTAT Hematocrit Evaluator 1
• Primary DI: 08426951293827
• Version / Model: 00044000104
• Catalog Number: 00044000104
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-06-26
• Public Version: 3
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: 3d5b1b42-d3d8-43f7-8a81-8d54a324c752

Device Description

ChemSTAT Hematocrit Evaluator 1, 10 ampoules x 1.8 mL

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
52868	Multiple electrolyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426951293827	GS1
Unit of Use	18426951293824	GS1

Customer Contacts

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

Storage Conditions

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