VERIFY

Basic Information

• Brand Name: VERIFY
• Primary DI: 10724995229495
• Version / Model: LCC016
• Catalog Number: LCC016
• Company Name: ALBERT BROWNE LIMITED
• Labeler DUNS: 218172765
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2024-04-08
• Public Version: 1
• Public Version Date: 2024-04-16
• Public Version Status: New
• Public Device Record Key: 26089f58-cf4e-40e4-9910-305378eab87f

Device Description

VERIFY Chemical Indicator for SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems

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	Medical device disinfection solution 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 the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995229493	GS1	Box	2	In Commercial Distribution
Primary	10724995229495	GS1
Unit of Use	00724995229498	GS1
Previous	10724995162600	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102217	000
K173428	000
K233654	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• 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