Thermo Scientific

Basic Information

• Brand Name: Thermo Scientific
• Primary DI: 10850685007019
• Version / Model: Heraeus Cryofuge 16
• Catalog Number: 75007673
• Company Name: Thermo Electron LED GmbH
• Labeler DUNS: 537396330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 1
• Public Version Date: 2018-10-22
• Public Version Status: New
• Public Device Record Key: e834ca6c-31ed-4bcb-b3ae-6a273b4e351f

Device Description

Heraeus Cryofuge 16, 200-240V, 50/60Hz

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: 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	10850685007019	GS1

Customer Contacts

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