ENFit Extension Set PNM-60ENENY

GUDID 00350770002019

60" Enteral Ext Set Bifurcated Purp

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 ID00350770002019
NIH Device Record Keyc83962a7-e78e-45f0-a0a0-bf2379505cb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameENFit Extension Set
Version Model NumberPNM-60ENENY
Catalog NumberPNM-60ENENY
Company DUNS079375431
Company NameAvanos Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100350770002019 [Primary]
GS120350770002013 [Package]
Package: CS [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, gastrointestinal (and accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-22
Device Publish Date2021-04-23

On-Brand Devices [ENFit Extension Set]

0035077000201960" Enteral Ext Set Bifurcated Purp
0035077000200260" Enteral Ext Set Bifurcated Orange
0035077000198260" Enteral Ext Set Standard Orange
0035077000196848" Enteral Ext Set Large Bore Purp
0035077000195148" Enteral Ext Set Large Bore Orange
0035077000193740" Enteral Ext Set XL Bore Orange
0035077000191318" Enteral Ext Set XL Bore Orange
0035077000034318" ENFit Ext Set XL Bore Purp
0035077000033640" ENFit Ext Set XL Bore Purp
003507700003298" ENFit Ext Set Bifurcated Purp
0035077000028260" ENFit Ext Set Bifurcated Purp
0035077000027560" ENFit Ext Set Standard Purp
0035077000026830” ENFit Ext Set Standard Purp
0035077000025130” ENFit Extension Set Standard Orange
0035077000024430” ENFit Ext Set XL Bore Orange
0035077000017648" ENFit Ext Set Large Bore Orange
0035077000016960" ENFit Ext Set Bifurcated Orange
0035077000015260" ENFit Ext Set Standard Orange

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