ENFit PU Feeding Tube FTXL8.0P-NC

GUDID 00350770000695

ENFit PU Feeding Tube Orange 8Fr 105cm

Avanos Medical, Inc.

Nasoenteral tube

• Primary Device ID: 00350770000695
• NIH Device Record Key: 4e42db42-26ca-4385-956d-181448597c89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit PU Feeding Tube
• Version Model Number: FTXL8.0P-NC
• Catalog Number: FTXL8.0P-NC
• Company DUNS: 079375431
• Company Name: Avanos Medical, Inc.
• 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

Customer Support Contacts

• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350770000695 [Primary]
GS1	20350770000699 [Package]; Package: CS [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082238

FDA Product Code

• BSS: TUBE, NASOGASTRIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-22
• Device Publish Date: 2021-04-02

On-Brand Devices [ENFit PU Feeding Tube]

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• 00350770001814: ENFit PU Feeding Tube Purp 8Fr 40cm
• 00350770001784: ENFit PU Feeding Tube Purp 6.5Fr 40cm
• 00350770001777: ENFit PU Feeding Tube Purp 5Fr 90cm
• 00350770001746: ENFit PU Feeding Tube Purp 4Fr 40cm
• 00350770000695: ENFit PU Feeding Tube Orange 8Fr 105cm
• 00350770000688: ENFit PU Feeding Tube Orange 5Fr 105cm
• 00350770000640: ENFit PU Feeding Tube Orange 12Fr 109cm
• 00350770000633: ENFit PU Feeding Tube Orange 10Fr 109cm
• 00350770000619: ENFit PU Feeding Tube Orange 6.5Fr 60cm
• 00350770000589: ENFit PU Feeding Tube Orange 6.5Fr 40cm