Prevention

Basic Information

• Brand Name: Prevention
• Primary DI: 10068460505135
• Version / Model: HLD8 Solution Test Strips
• Catalog Number: AHPHLD8
• Company Name: Virox Technologies Inc
• Labeler DUNS: 255343022
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2017-08-01
• Public Version: 4
• Public Version Date: 2021-09-29
• Public Version Status: Update
• Public Device Record Key: 83430e40-7467-44d7-bfa2-55615ebad80c

Device Description

A high level disinfectant concentration monitor dedicated for use with Prevention HLD8 High Level Disinfectant.

Device Characteristics

• Single Use: Yes
• 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
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10068460505135	GS1
Unit of Use	00068460505138	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			piece

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Keep away from direct light
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 6 – 30 Degrees Celsius