ENFit PU Feeding Tube FTXL5.0P-NC

GUDID 00350770000688

ENFit PU Feeding Tube Orange 5Fr 105cm

Avanos Medical, Inc.

Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube Nasoenteral tube

• Primary Device ID: 00350770000688
• NIH Device Record Key: 1c105986-083a-45e2-a750-08341dd73b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit PU Feeding Tube
• Version Model Number: FTXL5.0P-NC
• Catalog Number: FTXL5.0P-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	00350770000688 [Primary]
GS1	20350770000682 [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