FDA.reportPublic FDA data

Disposable Valve Sets

Primary DI
16970401818867
Brand
Disposable Valve Sets
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-A-AW01
Published
2022-07-07
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

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
K192258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192258000Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd.2019-12-30ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970401818867PackageGS150In Commercial Distribution
26970401818130PackageGS18In Commercial Distribution
06970401816125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181886716970401818867
2697040181813026970401818130
06970401816125069704018161256970401816125

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

Regulatory Flags#

DUNS number
544434963
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06936534328911Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810242026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810182026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815242026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815182026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825242026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825182026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410242026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410182026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415242026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415182026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425242026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425182026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810242026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810182026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815242026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815182026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825242026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825182026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410242026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410182026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957835Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957842Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957859Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
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04897106957903Champion 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
04897106957873Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2025-10-30