Instant 20s Indicator ISCS-05

GUDID 00860008246707

Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953 For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)

True Indicating LLC

Chemical/physical sterilization process indicator

• Primary Device ID: 00860008246707
• NIH Device Record Key: 5a4e9b69-d0cc-46b5-8c07-03cb721bf630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instant 20s Indicator
• Version Model Number: ISCS-05
• Catalog Number: ISCS-05
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008246707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210481

FDA Product Code

• MTC: Indicator, Chemical, Enzymatic, 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: 2023-05-22
• Device Publish Date: 2023-05-12

Devices Manufactured by True Indicating LLC

• 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
• 00860008246707 - Instant 20s Indicator: 2023-05-22Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953 For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
• 00860008246707 - Instant 20s Indicator: 2023-05-22 Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological table
• 00197644183036 - Excelsior Scientific: 2023-05-22 Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological table
• 00197644080601 - Sterim: 2023-05-08 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
• 00197644533428 - Sterim: 2023-05-08 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A