Approved MSCST-05SF

GUDID 00860008246769

Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)

True Indicating LLC

Biological sterilization indicator

• Primary Device ID: 00860008246769
• NIH Device Record Key: e2e004ec-7455-4b32-b958-8f03f153939e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Approved
• Version Model Number: MSCST-05SF
• Catalog Number: MSCST-05SF
• Company DUNS: 116935598
• Company Name: True Indicating LLC
• 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: 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: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com
• Phone: 419-476-7119
• Email: info@trueindicating.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008246769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200970

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: 2023-05-08
• Device Publish Date: 2023-04-28

Devices Manufactured by True Indicating LLC

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• 00850064244052 - Cheeta: 2025-04-10 The Cheeta Type 5 Integrating Indicator for Steam CHE-CSPN-15G is designed to chemically react over time with the critical para
• 00860011103424 - True Indicating Sterilization Indicator Tape: 2025-03-26 The Sterilization indicator tape is designed to demonstrate that the unit or load has been exposed to a sterilization process an
• 00850064244038 - True Indicating: 2025-03-07 The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical p
• 00850064244007 - True Indicating: 2024-05-09 True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stea
• 00860011103493 - Larr-Test 24: 2024-05-07 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
• 00860011103486 - True Indicating: 2024-04-15 True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stea
• 00860011103400 - Larr-Test 24: 2023-11-10 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A