Tuttnauer®

GUDID 07798164677475

Auto-Reader Incubator for biological indicators

TERRAGENE S.A.

Biological sterilization indicator reader

• Primary Device ID: 07798164677475
• NIH Device Record Key: e5b33612-f026-4d6a-9dbc-17f036df7b1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuttnauer®
• Version Model Number: WTL198-0057
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.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
• 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
• 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	07798164677475 [Primary]

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: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Tuttnauer®]

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• 07798375770248: Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
• 07798375770231: Moving front chemical integrator for steam sterilization processes.
• 07798375770286: Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes
• 07798375770262: Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes
• 07798164677666: Unique point Integrator Indicator for Steam sterilization processes.
• 07798164677697: Indicator Tape For Plasma or Vaporized Hydrogen Peroxide sterilization processes
• 07798375770279: Self-contained Biological Indicator for monitoring steam sterilization processes
• 07798375770255: Multivariable process indicator for monitoring Steam sterilization processes
• 07798164677390: Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
• 07798164677352: Super Adherent Indicator Tape For Steam sterilization processes.
• 07798164677475: Auto-Reader Incubator for biological indicators