Disposable Biopsy Valve

GUDID 06970401812585

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

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• Primary Device ID: 06970401812585
• NIH Device Record Key: 2a9e9429-0261-47f1-ae44-05cfc00de998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biopsy Valve
• Version Model Number: MD-A-BV01
• 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: 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	06970401812585 [Primary]
GS1	16970401813244 [Package]; Package: Box [100 Units]; In Commercial Distribution
GS1	26970401813258 [Package]; Contains: 16970401813244; 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: 4
• Public Version Date: 2018-09-26
• Device Publish Date: 2018-07-06

On-Brand Devices [Disposable Biopsy Valve]

• 26970401813548: MD-B-BV01
• 06970401812585: MD-A-BV01