FDA.reportPublic FDA data

Medivators Hookup

Primary DI
00677964085253
Brand
Medivators Hookup
Company
MEDIVATORS INC.
Model
Hookup
Catalog number
CLM110HU0108
Device description
Hookup, Adaptor Air/Water connects MEDIVATORS reprocessing equipment to endoscopes or related accessories.
Published
2023-04-10
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
NVEWasher, cleaner, automated, endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVEWasher, Cleaner, Automated, EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871712000MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.Machida America, Inc.1988-01-14NVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00677964085253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00677964085253006779640852536779640852530677964085253

GMDN Terms#

Term, Definition table
TermDefinition
Luminal device flushing tubing set, reusableA collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
068199363
Device count
1
Lot or batch
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
00677964072970Medivators HookupMEDIVATORS INC.NVE2024-04-01
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00677964089046Medivators HookupMEDIVATORS INC.NVE2023-10-16
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00677964064258Medivators HookupMEDIVATORS INC.NVE2023-04-10
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00677964089022Medivators HookupMEDIVATORS INC.NVE2023-04-10