FDA.reportPublic FDA data

Dovideq LeakControl Device

Primary DI
00816185001127
Brand
Dovideq LeakControl Device
Company
Torvan Medical Inc
Model
T11-ASY-LEAKCONTROL
Catalog number
T11-ASY-LEAKCONTROL
Device description
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.
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FCYBulb, Inflation, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCYBulb, Inflation, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816185001127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816185001127008161850011278161850011270816185001127

GMDN Terms#

Term, Definition table
TermDefinition
Invasive medical device leak tester, electricalAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
200280404
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816185001165AquaBrush SystemT12-TAB-402766T12-TAB-4027662025-12-08
00816185000397EndoCab4362SCSHG-20PSD2-TSBC4362SCSHG-20PSD2-TSBC2024-05-10
00816185000403EndoCab4352SCSHG-16PSD2-TSBC4352SCSHG-16PSD2-TSBC2024-05-10
00816185000410EndoCab4342SCSHG-10PSD1-TSBC4342SCSHG-10PSD1-TSBC2024-05-10
00816185000427EndoCab4322SCSLG-6PSD1-TSBC4322SCSLG-6PSD1-TSBC2024-05-10
00816185000441EndoCab4362SCSHG-20PSD2-TSRF4362SCSHG-20PSD2-TSRF2024-05-10
00816185000458EndoCab4352SCSHG-16PSD2-TSRF4352SCSHG-16PSD2-TSRF2024-05-10
00816185000465EndoCab4342SCSHG-10PSD1-TSRF4342SCSHG-10PSD1-TSRF2024-05-10
00816185000472EndoCab4322SCSLG-6PSD1-TSRF4322SCSLG-6PSD1-TSRF2024-05-10
00816185000847EndoCab4261SCSHG-20PTD2-TSRF4261SCSHG-20PTD2-TSRF2024-05-10
00816185000854EndoCab4251SCSHG-16PTD2-TSRF4251SCSHG-16PTD2-TSRF2024-05-10
00816185000861EndoCab4241SCSHG-10PTD1-TSRF4241SCSHG-10PTD1-TSRF2024-05-10
00816185000915EndoCab4253SCSHG-5PTD1-TSRF4253SCSHG-5PTD1-TSRF2024-05-10
00816185000922EndoCab4253SCSHG-10PTD1-TSRF4253SCSHG-10PTD1-TSRF2024-05-10
00816185000991EndoCab4261SCSHG-20PTD2-TSBC4261SCSHG-20PTD2-TSBC2024-05-10
00816185001004EndoCab4251SCSHG-16PTD2-TSBC4251SCSHG-16PTD2-TSBC2024-05-10
00816185001011EndoCab4241SCSHG-10PTD1-TSBC4241SCSHG-10PTD1-TSBC2024-05-10
00816185001066EndoCab4253SCSHG-5PTD1-TSBC4253SCSHG-5PTD1-TSBC2024-05-10
00816185001073EndoCab4253SCSHG-10PTD1-TSBC4253SCSHG-10PTD1-TSBC2024-05-10
00816185001141AutoSink with Endoscope Leak TesterT9-1B-3430HA-AST9-1B-3430HA-AS2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995360191NAMEDIVATORS INC.FCY2026-02-04
00724995360207NAMEDIVATORS INC.FCY2026-02-04
00724995360214NAMEDIVATORS INC.FCY2026-02-04
00724995360221NAMEDIVATORS INC.FCY2026-02-04
00724995360238NAMEDIVATORS INC.FCY2026-02-04
00724995360245NAMEDIVATORS INC.FCY2026-02-04
00724995244415NAMEDIVATORS INC.FCY2025-06-10
00724995244422NAMEDIVATORS INC.FCY2025-06-10
00724995244439NAMEDIVATORS INC.FCY2025-06-10
00724995244446NAMEDIVATORS INC.FCY2025-06-10
00724995244453NAMEDIVATORS INC.FCY2025-06-10
00724995244460NAMEDIVATORS INC.FCY2025-06-10
00724995244477NAMEDIVATORS INC.FCY2025-06-10
00724995244484NAMEDIVATORS INC.FCY2025-06-10
00724995244491NAMEDIVATORS INC.FCY2025-06-10
50724995244410NAMEDIVATORS INC.FCY2025-06-10
50724995244427NAMEDIVATORS INC.FCY2025-06-10
50724995244434NAMEDIVATORS INC.FCY2025-06-10
50724995244441NAMEDIVATORS INC.FCY2025-06-10
50724995244458NAMEDIVATORS INC.FCY2025-06-10
50724995244465NAMEDIVATORS INC.FCY2025-06-10
50724995244472NAMEDIVATORS INC.FCY2025-06-10
50724995244489NAMEDIVATORS INC.FCY2025-06-10
50724995244496NAMEDIVATORS INC.FCY2025-06-10
00816185001141AutoSink with Endoscope Leak TesterTorvan Medical IncFCY2025-04-28
00816185001158LT Connector 1OTorvan Medical IncFCY2025-04-28
06971919462156noneNingbo Albert Novosino Co.,Ltd.FCY2025-03-14
04048551054901n.a.Karl Storz GmbH & Co. KGFCY2024-11-29
04055207070055NARichard Wolf GmbHFCY2024-06-03
00850050934110EndoSound® Air Leak TesterEndosound, Inc.FCY2024-01-30