FDA.reportPublic FDA data

EndoSound® Air Leak Tester

Primary DI
00850050934110
Brand
EndoSound® Air Leak Tester
Company
Endosound, Inc.
Model
5030
Catalog number
5030
Device description
The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00850050934110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050934110008500509341108500509341100850050934110

GMDN Terms#

Term, Definition table
TermDefinition
Invasive medical device leak tester, mechanicalA hand-operated 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 is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure75 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(971) 231-4791info@endosound.com

Regulatory Flags#

DUNS number
111281644
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050934165EndoSound® Ultrasound Transducer Module (UTM)501650162024-10-31
10850050934186EndoSound® EVS™ Band Applicator501250122024-08-30
00850050934141EndoSound® EVS™ Bands1810250132024-06-14
00850050934011EndoSound® Transducer Extension Connector (TEC)500250022024-01-30
00850050934028EndoSound® EVSScanner500050002024-01-30
00850050934035EndoSound® Ultrasound Transducer Module (UTM)500150012024-01-30
00850050934042EndoSound® Ultrasound Disposable Kit (UDK-T) 5004500450032024-01-30
00850050934080EndoSound® Ultrasound Disposable Kit (UDK-T) 5006500650052024-01-30
00850050934097EndoSound® Ultrasound Disposable Kit (UDK-T) 5010501050092024-01-30
00850050934103EndoSound® Ultrasound Disposable Kit (UDK-T) 5008500850072024-01-30
00850050934127EndoSound® Vision System (EVS) Software501150112024-01-30

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
00816185001127Dovideq LeakControl DeviceTorvan Medical IncFCY2025-09-18
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
04547410520903FUJIFILMFUJIFILM CORPORATIONFCY2023-12-15
14547410520917FUJIFILMFUJIFILM CORPORATIONFCY2023-12-15
00817658022007Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21
00817658023790Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21
00817658023806Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21
00817658023813Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21
00817658023820Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21
00817658023837Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21
00817658023844Zutron MedicalZUTRON MEDICAL, L.L.C.FCY2023-09-21