VERIFY

Basic Information

• Brand Name: VERIFY
• Primary DI: 10724995084568
• Version / Model: Bowie Dick
• Catalog Number: EQC009
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 10
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: be6cb5b2-bb5f-44f0-92be-535d95e1784f
• Distribution End Date: 2022-11-02

Device Description

The VERIFY Bowie Dick Test Pack Air Removal is designed to monitor air removal and steam penetration during the preconditioning phase of some pre-vacuum steam sterilizer processing cycles.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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	50724995084573	GS1	Case	2	Not in Commercial Distribution	2021-12-10
Primary	10724995084568	GS1
Unit of Use	00724995084561	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002741	000
K162758	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid Direct Light
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit