Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 20304040103795
• Version / Model: 5701312
• Catalog Number: 5701312
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2019-01-11
• Public Version: 1
• Public Version Date: 2019-02-11
• Public Version Status: New
• Public Device Record Key: 43feeb9b-df60-4aa8-9bda-b05254e9adf6

Device Description

Microcuvettes

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: 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
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55875	Total haemoglobin (totHb) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20304040103795	GS1
Unit of Use	00304040103791	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius