DEVICE: AutoSink with Endoscope Leak Tester (00816185001141)
Device Identifier (DI) Information
AutoSink with Endoscope Leak Tester
T9-1B-3430HA-AS
In Commercial Distribution
T9-1B-3430HA-AS
Torvan Medical Inc
T9-1B-3430HA-AS
In Commercial Distribution
T9-1B-3430HA-AS
Torvan Medical Inc
The AutoSink supplements the manual cleaning process of endoscopes with added efficiencies and automations. Additionally providing early detection of small holes in the exterior of an endoscope through the observed detection of bubbles after submersion, it contributes to best practice, but does not replace required disinfection and maintainence.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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37006 | Invasive medical device leak tester, electrical |
An electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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FCY | Bulb, Inflation, For Endoscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
94656696-fe1c-4572-a8cd-24dd8ceac093
May 06, 2025
1
April 28, 2025
May 06, 2025
1
April 28, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined