FDA.reportPublic FDA data

andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit

Primary DI
04897106958603
Brand
andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit
Company
GA Health Company Limited
Model
101068
Published
2026-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897106958600PackageGS160In Commercial Distribution
24897106958607PackageGS14In Commercial Distribution
04897106958603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489710695860014897106958600
2489710695860724897106958607
04897106958603048971069586034897106958603

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.

Regulatory Flags#

DUNS number
686908512
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897106956081andorate® ThomasTrap ™ Polyp Trap 2.0GAR1040402026-03-18
04897106958566andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010472026-03-18
04897106958573andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010482026-03-18
04897106958597andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010672026-03-18
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
04897106957910andorate® 4-piece valve kit1010662026-03-12
04897106958559andorate® 4-piece valve kit1010462026-03-12
04897106958580andorate® 3-piece Valve Kit1010652026-03-12
04897106958610andorate® 4-piece valve kit1010812026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.ODC2025-01-10
08057502310108Endorail SetENDOSTART SRLODC2024-10-16
00724995197681DEFENDOUS EndoscopyODC2024-07-15
40677964031517ENDOGATORMEDIVATORS INC.OCX2024-05-29
00724995224035EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224059EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224189EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224202EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224226EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00191506040208AutoCap™ RXBOSTON SCIENTIFIC CORPORATIONODC2024-04-23
00724995229641DEFENDOMEDIVATORS INC.ODC2024-03-25
40677964030985ENDOGATORMEDIVATORS INC.OCX2024-02-29
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.OCX2024-01-22