FDA.reportPublic FDA data

andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit

Primary DI
04897106957941
Brand
andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit
Company
GA Health Company Limited
Model
101069
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897106957948PackageGS140In Commercial Distribution
24897106957945PackageGS14In Commercial Distribution
04897106957941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489710695794814897106957948
2489710695794524897106957945
04897106957941048971069579414897106957941

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
04897106958603andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010682026-03-18
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
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
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
04547410564112FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
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00850025860741Disposable Biopsy ValveMicro-tech UsaODC2025-03-04
008500258607583-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860765Disposable Biopsy ValveMicro-tech UsaODC2025-03-04
008500258608713-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860888Endoscopy Kit - Basic w Aux WaterMicro-tech UsaODC2025-03-04