VERIFY

Basic Information

• Brand Name: VERIFY
• Primary DI: 10724995087941
• Version / Model: PCC029
• Catalog Number: PCC029
• 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: 7
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: e837aabd-a138-4cc7-9f8a-f039ea354801
• Distribution End Date: 2020-05-22

Device Description

The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to an effective dose of peracetic acid. It is intended for use for routine monitoring of the Reliance EPS Endoscope Processing System employing Reliance DG Dry Germicide.

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
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
Package	50724995087949	GS1	Box	2	Not in Commercial Distribution	2020-05-22
Primary	10724995087941	GS1
Unit of Use	00724995087944	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063285	000

Storage Conditions

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