Disposable Biopsy Valve

GUDID 06970900850934

Yangzhou Fartley Medical Instrument Technology Co., Ltd

Endoscopic biopsy valve, single-use

• Primary Device ID: 06970900850934
• NIH Device Record Key: 4e93342d-c7a7-47ac-9a93-3bc91f19580f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biopsy Valve
• Version Model Number: FTL-BV-O-EO
• Company DUNS: 544375774
• Company Name: Yangzhou Fartley Medical Instrument 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970900850934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220210

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: 2023-10-27
• Device Publish Date: 2023-10-19

On-Brand Devices [Disposable Biopsy Valve]

• 06970900850934: FTL-BV-O-EO
• 06936603224397: FTL-BV-P
• 06936603224380: FTL-BV-F
• 06936603222409: FTL-BV-O
• 06936603217146: FTL-BV-P-EO
• 06936603217139: FTL-BV-F-EO
• 06936603225615: FTL-BV-F-EO/FTL-BV-O-EO