Disposable Valve Sets

GUDID 16970401815095

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit

• Primary Device ID: 16970401815095
• NIH Device Record Key: 8ab1202a-1914-458e-83cc-6b09daab26ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Valve Sets
• Version Model Number: MD-B-AW01
• Company DUNS: 544434963
• Company Name: Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970401815081 [Primary]
GS1	16970401815095 [Package]; Contains: 06970401815081; Package: Box [50 Units]; In Commercial Distribution
GS1	26970401815108 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192258

FDA Product Code

• ODC: Endoscope Channel Accessory

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

Devices Manufactured by Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

• 16970401815095 - Disposable Valve Sets: 2020-05-01
• 16970401815095 - Disposable Valve Sets: 2020-05-01
• 26970401814286 - Non-Rotatable Snares: 2019-10-31
• 26970401814262 - Non-Rotatable Snares: 2019-10-31
• 26970401814309 - Rotatable Snares: 2019-10-31
• 26970401813739 - Cleaning Brush: 2019-10-07
• 26970401813456 - Cleaning Brush: 2019-10-07
• 26970401813470 - Cleaning Brush: 2019-10-07
• 26970401813647 - Cleaning Brush: 2019-10-07