ENFit Extension Set EXT-48BNC

GUDID 00350770000176

48" ENFit Ext Set Large Bore Orange

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: 00350770000176
• NIH Device Record Key: 0753dffb-65d3-4926-aabf-7475ff501eb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit Extension Set
• Version Model Number: EXT-48BNC
• Catalog Number: EXT-48BNC
• 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	00350770000176 [Primary]
GS1	20350770000170 [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