Gastrostomy Feeding Tube with ENFit Connector 70-0068-116

GUDID 00813939025132

Gastrostomy Feeding Tube with ENFit Connector 16FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube Gastrostomy tube
Primary Device ID00813939025132
NIH Device Record Key0734112b-51b9-4588-a8ca-1c145bb6c308
Commercial Distribution StatusIn Commercial Distribution
Brand NameGastrostomy Feeding Tube with ENFit Connector
Version Model Number8884720163X
Catalog Number70-0068-116
Company DUNS183325125
Company NameXERIDIEM MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813939025064 [Primary]
GS100813939025132 [Package]
Contains: 00813939025064
Package: Case box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIFGastrointestinal Tubes With Enteral Specific Connectors

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2018-01-16

On-Brand Devices [Gastrostomy Feeding Tube with ENFit Connector]

00813939025170Gastrostomy Feeding Tube with ENFit Connector 24FR
00813939025163Gastrostomy Feeding Tube with ENFit Connector 22FR
00813939025156Gastrostomy Feeding Tube with ENFit Connector 20FR
00813939025149Gastrostomy Feeding Tube with ENFit Connector 18FR
00813939025132Gastrostomy Feeding Tube with ENFit Connector 16FR
00813939025125Gastrostomy Feeding Tube with ENFit Connector 14FR
00813939025118Gastrostomy Feeding Tube with ENFit Connector 12FR

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