FDA.reportPublic FDA data

NA

Primary DI
00724995244415
Brand
NA
Company
MEDIVATORS INC.
Model
Endo Leak Tester
Catalog number
ZUTR30005
Device description
Endo Leak Kit contains Endo Leak Tester, Calibration Adapter, Calibration Gauge, and power supply.
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
50724995244410PackageGS13In Commercial Distribution
00724995244415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499524441050724995244410
00724995244415007249952444157249952444150724995244415

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873custserv@medivators.com

Regulatory Flags#

DUNS number
068199363
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26
00677964153730Endo Carry-on Procedure Kit401123940112392026-05-26
00677964153747Endo Carry-on Procedure Kit401125140112512026-05-26
00677964153754Endo Carry-on Procedure Kit401125340112532026-05-26
00677964153761Endo Carry-on Procedure Kit401125440112542026-05-26
00677964153778Endo Carry-on Procedure Kit401136040113602026-05-26
00677964153785Endo Carry-on Procedure Kit401136140113612026-05-26
00677964057281Endo Carry-On Procedure Kit1008491008492018-06-22
00677964153488Endo Carry-on Procedure Kit401119340111932026-04-29

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
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