VERIFY

Basic Information

• Brand Name: VERIFY
• Primary DI: 10724995023833
• Version / Model: Dual Species
• Catalog Number: S306
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 6
• Public Version Date: 2020-11-03
• Public Version Status: Update
• Public Device Record Key: ada51395-3d1e-47a7-a4f3-7f76cc76649a

Device Description

The VERIFY Dual Species Self-Contained Biological Indicator is for use in installation testing and routine monitoring of steam sterilization processes employing dynamic air removal for prevacuum and SFPP or gravity preconditioning phases and ethylene oxide sterilization processes.

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
FRC	Indicator, biological sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995023824	GS1	Case	2	In Commercial Distribution
Primary	10724995023833	GS1
Unit of Use	00724995023836	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep from Heat
• Type: Special Storage Condition, Specify
• Special Conditions: Do not Freeze
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit