| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00816185001127 [Primary] |
| FCY | Bulb, Inflation, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-26 |
| Device Publish Date | 2025-09-18 |
| 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 |
| 00816185000106 - Connectors for EndoCab Series | 2024-05-20 TUBE SET - OLYMPUS - BIFURCATED |