Disposable Biopsy Valve 000522

GUDID 26970401814057

ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes

Zhejiang Chuangxiang Medical Technology Co., LTD.

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• Primary Device ID: 26970401814057
• NIH Device Record Key: da470c43-649c-47d4-b57d-dbe27c46f080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biopsy Valve
• Version Model Number: MDBV1A0000A
• Catalog Number: 000522
• 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	06970401812387 [Primary]
GS1	16970401814043 [Package]; Contains: 06970401812387; Package: Box [100 Units]; In Commercial Distribution
GS1	26970401814057 [Package]; Contains: 16970401814043; Package: Case [500 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: 2022-07-18
• Device Publish Date: 2019-06-18

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