Disposable Endoscopy Valve Set 115281

GUDID 16936603226909

PENTAX i20 type: Cleaning Valve

Yangzhou Fartley Medical Instrument Technology Co., Ltd

Endoscope channel support kit

• Primary Device ID: 16936603226909
• NIH Device Record Key: 73b45afb-a6de-4f69-b139-bbc5c988d1a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Endoscopy Valve Set
• Version Model Number: FTL-VS-PI20-J
• Catalog Number: 115281
• 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	06936603226902 [Primary]
GS1	16936603226909 [Package]; Contains: 06936603226902; Package: Sales Packaging [100 Units]; In Commercial Distribution
GS1	26936603226906 [Package]; Package: Shipping Carton [4 Units]; In Commercial Distribution

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: 2025-08-29
• Device Publish Date: 2025-08-21

On-Brand Devices [Disposable Endoscopy Valve Set]

• 06936603224410: FTL-VS-PI20-C
• 06936603224403: FTL-VS-PI20-B
• 06936603210567: FTL-VS-PI20-A
• 16936603226909: PENTAX i20 type: Cleaning Valve