FDA.reportPublic FDA data

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

Primary DI
14897106957955
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
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
686908512
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
true
Sterilization required before use
false

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
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
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
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
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
04897106955718andorate® 2-piece Cleaning Adapter+ 3-piece Valve KitGA Health Company LimitedODC2025-07-30