Disposable Auxiliary Water Jet Adapter 408406024

GUDID 06936603230039

Yangzhou Fartley Medical Instrument Technology Co., Ltd

Endoscope channel support kit

• Primary Device ID: 06936603230039
• NIH Device Record Key: 9fa47c2d-6869-4e6c-a73f-40d578839e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Auxiliary Water Jet Adapter
• Version Model Number: FTL-VS-F-WJ
• Catalog Number: 408406024
• 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	06936603230039 [Primary]
GS1	16936603230036 [Package]; Package: Sales box [100 Units]; In Commercial Distribution
GS1	26936603230033 [Package]; Contains: 16936603230036; 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: 2025-03-24
• Device Publish Date: 2025-03-14

Devices Manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd

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• 16936603230869 - Bedside Cleaning Sponge: 2025-07-01 Sentrus Cleaning Sponge, Sponge +enzymatic, tray
• 16936603230876 - Basic Bedside Kit: 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker
• 16936603230883 - Basic Bedside Kit: 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br
• 16936603230890 - Basic Bedside Kit: 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br
• 16936603230906 - Basic Bedside Kit: 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br
• 16936603230913 - Basic Bedside Kit: 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br
• 16936603230975 - Cleaning Sponge: 2025-07-01 Sentrus Cleaning Sponge, cleaning sponge (without tray)