Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 00304040043394
• Version / Model: 1126913
• Catalog Number: 1126913
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-03
• Public Version: 1
• Public Version Date: 2022-05-11
• Public Version Status: New
• Public Device Record Key: 97048429-2166-4da3-8bfb-851b69b821c3

Device Description

Vortex Mixer Tube Mini

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64819	Vortex mixer IVD	An electrically-powered laboratory instrument intended to be used to mix small volumes of liquid or solution, or to resuspend sediment, in a container (e.g., test tube, microplate) using a vortex during the processing of a clinical specimen. It typically consists of a shaft or platform on which the specimen container is placed, and a motor to generate the force required to create the vortex within the specimen container resulting in a mixing effect. The device may have the capacity to process one or multiple containers at the same time, at variable revolutions per minute (RPM).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304040043394	GS1