Revital-Ox Resert

Basic Information

• Brand Name: Revital-Ox Resert
• Primary DI: 00724995095017
• Version / Model: 4455AW
• Catalog Number: 4455AW
• Company Name: STERIS CORPORATION
• Labeler DUNS: 139424188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 9
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: b42873a0-6069-4a48-bf28-308c9a52a6b2

Device Description

Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for processing semi-critical medical devices for which alternative methods of terminal processing are not suitable or available. It is for use in both manual soaking and automated endoscope processors. It must be used with Revital-Ox RESERT R60 Solution Test Strips.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MED	Sterilant, medical devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47631	Medical device disinfection agent	A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995095012	GS1	Case	4	In Commercial Distribution
Primary	00724995095017	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Liter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep in original container
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 65 Percent (%) Relative Humidity