VERIFY

Basic Information

• Brand Name: VERIFY
• Primary DI: 10724995172593
• Version / Model: PCC071
• Catalog Number: PCC071
• Company Name: STERIS CORPORATION
• Labeler DUNS: 868205779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-01-06
• Public Version: 5
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: 2e88b94d-d4a7-4ce7-8d15-2201ff89e560

Device Description

The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX Sterilizers.

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
Primary	10724995172593	GS1
Unit of Use	00724995172596	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160485	000
K183293	000
K231488	000

Device Sizes

Type	Value	Unit	Text
Length	60	Yard

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 16 – 24 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and away from sunlight. Do Not store near heat, moisture, oxidizing agents, acids/alkalis, or cleaning/disinfecting agents.