Identity
- Trade Name
- AutoSink with Endoscope Leak Tester FDA UDI
- Generic Name
- Invasive medical device leak tester, electrical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- T9-1B-3430HA-AS FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- T9-1B-3430HA-AS FDA UDI
- Primary DI / UDI-DI
- 00816185001141 FDA UDI
- FDA Product Code
- FCY FDA UDI
- GMDN Term
- Invasive medical device leak tester, electrical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive medical device leak tester, electrical
AutoSink with Endoscope Leak Tester by Torvan Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Torvan Medical Inc
Sources (1)
- FDA UDI 94656696-fe1c-4572-a8cd-24dd8ceac093 34 fields · synced Jun 1, 2026