trueindicating.comType 5 Integrating Indicator for Steam (CSPN-15)
True Indicating, LLC
TRUE INDICATING LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017524825 | 3017524825 | TRUE INDICATING LLC | 1 | N | 2026-01-01 | 946 Kane St Suite A Toledo OH US 43612 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00197644183036 | Excelsior Scientific - 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® 7953For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum) | 419-476-7119 | info@trueindicating.com |
| 00850064244007 | True Indicating - 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 10^5 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. One box contains 100 SCBIs.For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum) | 419-476-7119 | info@trueindicating.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 286005 | 1341704317 | K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | JOJ | 2025-01-17 |
| 286005 | 1872517599 | K210481 | Instant 20s Indicator | MTC | 2021-12-14 |
| 286005 | 1034323735 | K200970 | Self-Contained Biological Indicator | FRC | 2020-12-28 |
| 286005 | 1714994916 | K171823 | U&U Indicator tape and strip | JOJ | 2018-02-22 |
Product Codes Associated With Registrations#
PMN#
Ultraphon Chemical Indicator (TRO-T and TRO-B)
True Indicating, LLC
Chemical Indicator For Steam
True Indicating LLC
Instant 20s Indicator
True Indicating, LLC
Self-Contained Biological Indicator
True Indicating, LLC
GUDID#
True Indicating Sterilization Indicator Tape - The Sterilization indicator tape is designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off-yellow to Dark brown/Black. Use the Sterilization indicator tape in steam sterilization processes described below. 1. 121°C, 30 minutes; Gravity Steam 2. 132°C, 4 minutes; Dynamic Air Removal Steam 3. 135°C, 3 minutes; Dynamic Air Removal Steam
2025-03-18
True Indicating - 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)
2024-04-05
Larr - The Larr Type 5 Integrating Indicator for Steam CSPN-15L is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121 ° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121 °C/16.5 min., SV132°C/2.0min, SV134 °C/1.4 min. SV135°C/1.2 min.
2025-04-02
Cheeta - The Cheeta Type 5 Integrating Indicator for Steam CHE-CSPN-15G is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121 ° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121 °C/16.5 min., SV132°C/2.0min, SV134 °C/1.4 min. SV135°C/1.2 min.
2025-04-02
True Indicating - The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121 ° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121 °C/16.5 min., SV132°C/2.0min, SV134 °C/1.4 min. SV135°C/1.2 min.
2025-02-27
Instant 20s Indicator - 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® 7953For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
2023-05-12
Excelsior Scientific - 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® 7953For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
2023-05-12
True Indicating - 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 10^5 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. One box contains 100 SCBIs.For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2024-05-01
Larr-Test 24 - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2024-04-29
Larr-Test 24 - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-11-02
Sterim - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-04-28
Sterim - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-04-28
True Indicating - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-04-28
Excelsior Scientific - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-04-28
Larr-Test 24 - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-04-28
Approved - 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 PurpleFor Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
2023-04-28