FDA.reportPublic FDA data

andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit

Primary DI
04897106957958
Brand
andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit
Company
GA Health Company Limited
Model
101070
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
OCXEndoscopic Irrigation/Suction System
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897106957955PackageGS140In Commercial Distribution
24897106957952PackageGS14In Commercial Distribution
04897106957958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489710695795514897106957955
2489710695795224897106957952
04897106957958048971069579584897106957958

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
04897106955060Four Chamber Polyp Trap (Non-sterile)EN10103.42022-03-25
04897106955091Single Chamber Polyp Trap (Non-sterile)EN10113.12022-03-25
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
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551432822ENDOMAT SELECTKarl Storz GmbH & Co. KGOCX2026-11-02
06936603216187Kirei FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-25
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06936603235508CO2 AdapterYangzhou Fartley Medical Instrument Technology Co., LtdFFY2026-10-25
06936603212301Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212318Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212424Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212448Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212462Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212479Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
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
04897129991755CeroFrictSML Med-Tech Solutions LimitedFFY2026-10-13
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04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONOCX2026-08-25
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B382SD20260Surgical DirectSurgical Direct, Inc.OCX2026-08-03
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00724995356699CLEANASCOPESTERIS ITALY SRLFFY2026-05-26
00724995356705CLEANASCOPESTERIS ITALY SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGESTERIS ITALY SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGESTERIS ITALY SRLFFY2026-05-26
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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