ROTANTA 460 RF

Basic Information

• Brand Name: ROTANTA 460 RF
• Primary DI: 04050674078160
• Version / Model: ROTANTA 460 RF - 100V-127V/50-60Hz
• Catalog Number: 5675-01
• 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: 2021-09-02
• Public Version: 1
• Public Version Date: 2021-09-10
• Public Version Status: New
• Public Device Record Key: fa01a3d9-acfc-41e7-9251-6ae50e0e592d

Device Description

Floor standing centrifuge, refrigerated

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
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	864.9275	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15117	Low-speed floor centrifuge, refrigerated	A freestanding mains electricity (AC-powered) device used mainly in the clinical laboratory to process through low-speed centrifugal force (typically up to 10,000 rpm) a large volume of clinical specimens (e.g., body fluids, reagents) at cool temperatures. It is typically a large stationary structure with an electric motor, a shaft, a tachometer, and speed and time controls; it also includes a rotor for mounting one of several interchangeable heads with slots to fit tubes and other sample holders, and a compressor to keep the rotor chamber cool. The device helps to control the temperature in temperature-sensitive laboratory assays such as some enzyme and complement tests.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050674078160	GS1