Disposable Valve Sets

GUDID 16970401818867

Zhejiang Chuangxiang Medical Technology Co., LTD.

Endoscope channel support kit
Primary Device ID16970401818867
NIH Device Record Key63a3082d-eb4c-4db0-aaea-1d852e2fc3b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Valve Sets
Version Model NumberMD-A-AW01
Company DUNS544434963
Company NameZhejiang Chuangxiang Medical Technology Co., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970401816125 [Primary]
GS116970401818867 [Package]
Contains: 06970401816125
Package: Box [50 Units]
In Commercial Distribution
GS126970401818130 [Package]
Package: Case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODCEndoscope Channel Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-15
Device Publish Date2022-07-07

Devices Manufactured by Zhejiang Chuangxiang Medical Technology Co., LTD.

06970401812240 - Polyp Trap2024-08-06
06936534331614 - Polyp Trap2024-07-30 EO sterile
06970401816910 - Polyp Trap2024-07-30 EO sterile
06970401814039 - Polyp Trap2024-07-22 EO sterile
06936534332260 - Air/Water Bottle Tubing2023-12-26
06936534338675 - Endoscopy Irrigation Tubing2023-12-26
06936534338682 - Endoscopy Irrigation Tubing2023-12-26
06936534325439 - Single Use Urinary Guidewire2023-12-05

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