BIOTRACE™

GUDID 07798375772495

BIOTRACE™ Rapid Read 5 VH2O2 Biological Indicator Reader

TERRAGENE S.A.

Biological sterilization indicator reader

• Primary Device ID: 07798375772495
• NIH Device Record Key: d6c8e1ea-bc3d-4e58-b6b2-0be1c4ab9f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOTRACE™
• Version Model Number: 73420
• Company DUNS: 970856911
• Company Name: TERRAGENE S.A.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• 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 Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07798375772495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221641

FDA Product Code

• FRC: Indicator, Biological 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: 2025-03-14
• Device Publish Date: 2025-03-06

On-Brand Devices [BIOTRACE™]

• 07798375772488: BIOTRACE™ Auto Read Mini Biological Indicator Reader.
• 07798375772471: BIOTRACE™ Auto Read Pro Biological Indicator Reader.
• 07798375772464: BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device
• 07798375772457: BIOTRACE™ Auto Read 20 Steam Biological Indicator
• 07798375772990: BIOTRACE™ Auto Read 4H EO Biological Indicator
• 07798375773003: BIOTRACE™ Auto Read 60 Steam Biological Indicator
• 07798375772877: BIOTRACE™ Auto Read 60 Steam BI Process Challenge Device
• 07798375773041: BIOTRACE™ Instant Read Steam Biological Indicator
• 07798375772501: BIOTRACE™ Instant Read Steam Biological Indicator Reader
• 07798375772495: BIOTRACE™ Rapid Read 5 VH2O2 Biological Indicator Reader