Prevention

Basic Information

• Brand Name: Prevention
• Primary DI: 00068460505190
• Version / Model: HLD8 High Level Disinfectant
• Catalog Number: 25505
• Company Name: Virox Technologies Inc
• Labeler DUNS: 255343022
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-01
• Public Version: 8
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 0f59f432-d281-4460-9832-9075af5a076e

Device Description

A reusable high level disinfectant solution designed to be used with heat sensitive medical devices and instruments, for which heat sterilization is not suitable.

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: 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	10068460505197	GS1	Case	4	In Commercial Distribution
Primary	00068460505190	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091022	000

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Liter

Storage Conditions

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