Disposable Biopsy Valve

GUDID 16970401817150

Non-sterile

Zhejiang Chuangxiang Medical Technology Co., LTD.

Endoscopic biopsy valve, single-use

• Primary Device ID: 16970401817150
• NIH Device Record Key: 86f51065-b0b9-4cc4-b752-0e61b588c305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biopsy Valve
• Version Model Number: MD-B-BV02
• Company DUNS: 544434963
• Company Name: Zhejiang 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	06970401817146 [Primary]
GS1	16970401817150 [Package]; Contains: 06970401817146; Package: Box [100 Units]; In Commercial Distribution
GS1	26970401817164 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173758

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [Disposable Biopsy Valve]

• 16970401817150: Non-sterile
• 16970401817174: MD-A-BV02
• 26970401814361: product color: purple
• 26970401814071: ClearGuard Disposable Biopsy Valve for Pentax GI Endoscopes
• 26970401814057: ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes