VERISURE™

GUDID 07798375772754

VERISURE™ Bowie-Dick Test Card

TERRAGENE S.A.

Chemical/physical sterilization process indicator

• Primary Device ID: 07798375772754
• NIH Device Record Key: c09f9133-7c6f-4fbe-b3d5-616939f15a0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERISURE™
• Version Model Number: 73191
• Company DUNS: 970856911
• Company Name: TERRAGENE S.A.
• Device Count: 120
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07798375772549 [Unit of Use]
GS1	07798375772747 [Primary]
GS1	07798375772754 [Package]; Contains: 07798375772747; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200272

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [VERISURE™]

• 07798375772235: VERISURE™ Steam Type 5 Migrating Integrator Process Challenge Device
• 07798375772211: VERISURE™ Steam Type 5 Migrating Integrator
• 07798375772198: VERISURE™ Bowie-Dick Test Pack
• 07798375772228: VERISURE™ Steam Type 5 Migrating Integrator w/ Extender
• 07798375772969: VERISURE™ Steam Type 5 Ink Integrator
• 07798375772907: VERISURE™ Steam Type 4 Multi-Variable Chemical Indicator
• 07798375772846: VERISURE™ EO Type 4 Multi-Variable Chemical Indicator Strip
• 07798375772808: VERISURE™ VH2O2 Type 4 Multi-Variable Chemical Indicator Strip
• 07798375772754: VERISURE™ Bowie-Dick Test Card
• 07798375772532: VERISURE™ Bowie-Dick Test Card Kit