ENFit Extension Set PEXT-40BNC

GUDID 00350770000336

40" ENFit Ext Set XL Bore Purp

Avanos Medical, Inc.

Nasoenteral tube

• Primary Device ID: 00350770000336
• NIH Device Record Key: 15f76e37-1243-4626-9a7b-8ebf0e78241f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit Extension Set
• Version Model Number: PEXT-40BNC
• Catalog Number: PEXT-40BNC
• 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: true
• 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	00350770000336 [Primary]
GS1	20350770000330 [Package]; Package: CS [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100288

FDA Product Code

• KNT: Tubes, gastrointestinal (and accessories)

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 Extension Set]

• 00350770002019: 60" Enteral Ext Set Bifurcated Purp
• 00350770002002: 60" Enteral Ext Set Bifurcated Orange
• 00350770001982: 60" Enteral Ext Set Standard Orange
• 00350770001968: 48" Enteral Ext Set Large Bore Purp
• 00350770001951: 48" Enteral Ext Set Large Bore Orange
• 00350770001937: 40" Enteral Ext Set XL Bore Orange
• 00350770001913: 18" Enteral Ext Set XL Bore Orange
• 00350770000343: 18" ENFit Ext Set XL Bore Purp
• 00350770000336: 40" ENFit Ext Set XL Bore Purp
• 00350770000329: 8" ENFit Ext Set Bifurcated Purp
• 00350770000282: 60" ENFit Ext Set Bifurcated Purp
• 00350770000275: 60" ENFit Ext Set Standard Purp
• 00350770000268: 30” ENFit Ext Set Standard Purp
• 00350770000251: 30” ENFit Extension Set Standard Orange
• 00350770000244: 30” ENFit Ext Set XL Bore Orange
• 00350770000176: 48" ENFit Ext Set Large Bore Orange
• 00350770000169: 60" ENFit Ext Set Bifurcated Orange
• 00350770000152: 60" ENFit Ext Set Standard Orange