True Indicating

GUDID 00860011103486

True Indicating 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, sold as 25 units per box. 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: 00860011103486
• NIH Device Record Key: 301814df-afd9-4848-8430-61e8886311b3
• Commercial Distribution Discontinuation: 2025-05-16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Indicating
• Version Model Number: MSCST-05-25
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011103486 [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: 2024-04-15
• Device Publish Date: 2024-04-05

On-Brand Devices [True Indicating]

• 00860008246714: True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc
• 00860011103486: True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc
• 00850064244007: True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc