Disposable Endoscopy Valve Set 115284

GUDID 06936603224410

Yangzhou Fartley Medical Instrument Technology Co., Ltd

Endoscope channel support kit

• Primary Device ID: 06936603224410
• NIH Device Record Key: 8a5d69f8-0b63-4db0-a65e-37171376a1d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Endoscopy Valve Set
• Version Model Number: FTL-VS-PI20-C
• Catalog Number: 115284
• 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	06936603224410 [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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [Disposable Endoscopy Valve Set]

• 06936603224410: FTL-VS-PI20-C
• 06936603224403: FTL-VS-PI20-B
• 06936603210567: FTL-VS-PI20-A