AutoSink with Endoscope Leak Tester T9-1B-3430HA-AS

GUDID 00816185001141

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.

Torvan Medical Inc

Invasive medical device leak tester, electrical

• Primary Device ID: 00816185001141
• NIH Device Record Key: 94656696-fe1c-4572-a8cd-24dd8ceac093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoSink with Endoscope Leak Tester
• Version Model Number: T9-1B-3430HA-AS
• Catalog Number: T9-1B-3430HA-AS
• Company DUNS: 200280404
• Company Name: Torvan Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816185001141 [Primary]

FDA Product Code

• FCY: Bulb, Inflation, For Endoscope

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: 2025-05-06
• Device Publish Date: 2025-04-28

Devices Manufactured by Torvan Medical Inc

• 00816185001141 - AutoSink with Endoscope Leak Tester: 2025-05-06The 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.
• 00816185001141 - AutoSink with Endoscope Leak Tester: 2025-05-06 The AutoSink supplements the manual cleaning process of endoscopes with added efficiencies and automations. Additionally providi
• 00816185001158 - LT Connector 1O: 2025-05-06
• 00816185001080 - EndoCab: 2024-12-09 ENDOCABINET, SIDELOAD, 6-SCOPE (LEFT), ADD-ON, PURGE-TRACKING
• 00816185001097 - EndoCab: 2024-12-09 ENDOCABINET, SIDELOAD, 10-SCOPE, ADD-ON, PURGE-TRACKING
• 00816185001103 - EndoCab: 2024-12-09 ENDOCABINET, SIDELOAD, 16-SCOPE, ADD-ON, PURGE-TRACKING
• 00816185001110 - EndoCab: 2024-12-09 ENDOCABINET, SIDELOAD, 20-SCOPE, ADD-ON, PURGE-TRACKING
• 00816185000106 - Connectors for EndoCab Series: 2024-05-20 TUBE SET - OLYMPUS - BIFURCATED
• 00816185000113 - Connectors for EndoCab Series: 2024-05-20 TUBE SET - OLYMPUS - TRIFURCATED - TOP AUXILIARY WATER CHANNEL