FDA.reportPublic FDA data

NA

Primary DI
10724995247307
Brand
NA
Company
MEDIVATORS INC.
Model
10034100
Catalog number
10034100
Device description
Olympus Bronchoscope 2-piece Valve Kit, US
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232118000ANDORATE® Valve KitGa Health Company Limited2023-10-16ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995247307PackageGS150In Commercial Distribution
00724995247300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499524730710724995247307
00724995247300007249952473007249952473000724995247300

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00677964154133Endo Carry-on Procedure Kit401156440115642026-10-28
00677964154140Endo Carry-on Procedure Kit401156540115652026-10-28
00677964154157Endo Carry-on Procedure Kit401156740115672026-10-28
00677964154164Endo Carry-on Procedure Kit401157740115772026-10-28
00677964154171Endo Carry-on Procedure Kit401157840115782026-10-28
00677964154188Endo Carry-on Procedure Kit401169040116902026-10-28
00677964154195Endo Carry-on Procedure Kit401168040116802026-10-28
00677964154201Endo Carry-on Procedure Kit401168240116822026-10-28
00677964154218Endo Carry-on Procedure Kit401168340116832026-10-28
00677964154225Endo Carry-on Procedure Kit401168440116842026-10-28
00677964154232Endo Carry-on Procedure Kit401168540116852026-10-28
00677964154249Endo Carry-on Procedure Kit401168640116862026-10-28
00677964154256Endo Carry-on Procedure Kit401158140115812026-10-28
00677964154263Endo Carry-on Procedure Kit401168140116812026-10-28
00677964154270Endo Carry-on Procedure Kit401169640116962026-10-28
00677964154287Endo Carry-on Procedure Kit401169740116972026-10-28
00677964154294Endo Carry-on Procedure Kit401170240117022026-10-28
00677964154300Endo Carry-on Procedure Kit401170140117012026-10-28
00677964154317Endo Carry-on Procedure Kit401171240117122026-10-28
00677964154324Endo Carry-on Procedure Kit401171340117132026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603216187Kirei FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-25
06936603216200Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216224Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216231Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216248Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216262Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
00850025860970Endoscopy Kit - Basic Aux HBMicro-tech UsaODC2026-10-12
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONODC2026-08-25
06973141950845EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2026-07-16
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957835Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957576andorate® Champion 3-piece Valve KitGA Health Company LimitedODC2025-11-21
04897106957583andorate® Champion 4-piece valve kitGA Health Company LimitedODC2025-11-21
04897106957644Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2025-10-30