Disposable Biopsy Valve

GUDID 26970401814361

product color: purple

Zhejiang Chuangxiang Medical Technology Co., LTD.

Endoscopic biopsy valve, single-use

• Primary Device ID: 26970401814361
• NIH Device Record Key: 42c2a833-2c0c-4536-b594-03f9e74c0c87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biopsy Valve
• Version Model Number: MD-A-BV01
• 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	06970401814343 [Primary]
GS1	16970401814357 [Package]; Contains: 06970401814343; Package: Box [100 Units]; In Commercial Distribution
GS1	26970401814361 [Package]; Contains: 16970401814357; 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-03-19
• Device Publish Date: 2019-12-24

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