Dovideq LeakControl Device T11-ASY-LEAKCONTROL

GUDID 00816185001127

The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope.

Torvan Medical Inc

Invasive medical device leak tester, electrical

• Primary Device ID: 00816185001127
• NIH Device Record Key: d96cc5f3-8780-4958-8b10-a41d7f29bef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dovideq LeakControl Device
• Version Model Number: T11-ASY-LEAKCONTROL
• Catalog Number: T11-ASY-LEAKCONTROL
• 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	00816185001127 [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: 2025-09-26
• Device Publish Date: 2025-09-18

Devices Manufactured by Torvan Medical Inc

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• 00816185001127 - Dovideq LeakControl Device: 2025-09-26The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope.
• 00816185001127 - Dovideq LeakControl Device: 2025-09-26 The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of a
• 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