UNIVERSAL 320 R

Basic Information

• Brand Name: UNIVERSAL 320 R
• Primary DI: 04050674038263
• Version / Model: 1406-01
• Catalog Number: 1406-01
• Company Name: Andreas Hettich GmbH & Co. KG
• Labeler DUNS: 316403245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 7960882e-4277-4bae-8b68-5c322a1bf472

Device Description

refrigerated bench-top centrifuge without rotor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
GKG	Centrifuge, Hematocrit	Hematology	864.6400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36465	General-purpose centrifuge IVD	An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050674038263	GS1