FDA.reportPublic FDA data

Disposable Valve Sets

Primary DI
16970401815095
Brand
Disposable Valve Sets
Company
Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
Model
MD-B-AW01
Published
2020-04-23
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
16970401815095PackageGS150In Commercial Distribution
26970401815108PackageGS18In Commercial Distribution
06970401815081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181509516970401815095
2697040181510826970401815108
06970401815081069704018150816970401815081

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
26970401814286Non-Rotatable SnaresMD-E-SNC2415242019-10-23
26970401814262Non-Rotatable SnaresMD-E-SNC2432242019-10-23
26970401814309Rotatable SnaresMD-E-SNR2415242019-10-23
26970401813739Cleaning BrushMD-A-BR-23062019-01-09
26970401813456Cleaning BrushMD-B-BR-23062018-11-23
26970401813470Cleaning BrushMD-B-BR-05102018-11-23
26970401813647Cleaning BrushMD-D-BR-05102018-12-10
26970401814248Single Use Biopsy ForcepsMD-B-BF24182019-09-25
26970401813975Single Use Biopsy ForcepsMD-C-BF24032019-06-04
26970401814002Single Use Grasping ForcepsMD-C-GF24032019-06-04
26970401813944Single Use Biopsy ForcepsMD-A-BF24182019-04-29
26970401812862Single Use HemoclipMD-L-HR-270-15-135-Y2019-03-22
26970401813913Single Use GuidewireMD-S-GW35452019-03-23
26970401813890Single Use HemoclipMD-C-HR-270-13-135-Y2019-03-22
26970401813401Single Use Biopsy ForcepsMD-A-BF24162019-02-26
26970401813845Disposable Bite BlockMD-BB-CY-012019-02-26
26970401813210Rotatable SnaresMD-E-SNR2432242018-09-25
26970401813715Single Use HemoclipMD-G-HR-230-12-135-N2019-01-08
16970401813671Single Use Biopsy ForcepsMD-B-BF24232019-01-04
26970401813517Single Use Biopsy ForcepsMD-A-BF24232018-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957910andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957972andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
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
04897106957866Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957903Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957927Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957934Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2026-01-21