Cenorin

Basic Information

• Brand Name: Cenorin
• Primary DI: 00852494007085
• Version / Model: 610HT
• Company Name: CENORIN, L.L.C.
• Labeler DUNS: 157362497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-15
• Public Version: 1
• Public Version Date: 2021-07-23
• Public Version Status: New
• Public Device Record Key: e2f6a1a0-6a4a-42eb-b946-6556991c6d0d

Device Description

Washer-Pasteuerizer/High Level Disinfector

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: No
• 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
LDS	Device, Pasteurization, Hot Water	General Hospital	880.6991	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44555	Pasteurization water bath	A device usually in the form of a small heated water bath intended to be used to kill most infective agents on instruments by heating in water to 70? to 75? Celsius for a minimum of 20 minutes. This procedure is intended to provide disinfection for items where total sterility is not required.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852494007085	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183444	000