Revital-Ox Resert

Basic Information

• Brand Name: Revital-Ox Resert
• Primary DI: 10724995002227
• Version / Model: PCC054
• Catalog Number: PCC054
• Company Name: ALBERT BROWNE LIMITED
• Labeler DUNS: 218172765
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 5
• Public Version Date: 2020-05-22
• Public Version Status: Update
• Public Device Record Key: 0d359eb6-d91b-4df9-8fb8-3cc8a0f9c0f0
• Distribution End Date: 2020-05-22

Device Description

The Revital-Ox Resert R60 Solution Test Strip is a chemical indicator designed exclusively for monitoring of Revital-Ox RESERT High Level Solutions.

Device Characteristics

• Single Use: Yes
• 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
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58056	Peracetic acid device disinfectant/sterilant test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of peracetic acid in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995002225	GS1	Box	2	Not in Commercial Distribution	2020-05-22
Primary	10724995002227	GS1
Unit of Use	00724995002220	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Keep away from direct light
• Type: Storage Environment Temperature
• Temperature Range: 43 – 86 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity