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
00816185001141
GS1

1
200280404 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
FCY Bulb, Inflation, For Endoscope
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

94656696-fe1c-4572-a8cd-24dd8ceac093
May 06, 2025
1
April 28, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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