FDA.reportPublic FDA data

Medivators Hookup

Primary DI
00677964085284
Brand
Medivators Hookup
Company
MEDIVATORS INC.
Model
Hookup
Catalog number
CLM110HU0130
Device description
Hookup, OLYMPUS Universal Air 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
00677964085284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00677964085284006779640852846779640852840677964085284

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
00677964089039Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089091Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089046Medivators HookupMEDIVATORS INC.NVE2023-10-16
00677964033070Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064210Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064227Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064258Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064296Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064302Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064326Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064333Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064340Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064357Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064364Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064371Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085222Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085246Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085253Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085260Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085277Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085291Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088957Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088964Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088971Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088988Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088995Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089008Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089015Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089022Medivators HookupMEDIVATORS INC.NVE2023-04-10