Gastrostomy Tube with ENFit connector 70-0064-116

GUDID 20888277411040

Gastrostomy Tube with ENFit connector, 16FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube
Primary Device ID20888277411040
NIH Device Record Keydac9d788-515e-4e9e-8a28-5f900c7421d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGastrostomy Tube with ENFit connector
Version Model NumberENFIT70316
Catalog Number70-0064-116
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
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com
Phone(520) 882-7794
Emailsmurray@xeridiem.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888277411043 [Primary]
GS120888277411040 [Package]
Contains: 10888277411043
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 Number5
Public Version Date2020-04-20
Device Publish Date2016-08-08

On-Brand Devices [Gastrostomy Tube with ENFit connector]

20888277411088Gastrostomy Tube with ENFit connector, 24FR
20888277411071Gastrostomy Tube with ENFit connector 22FR
20888277411064Gastrostomy Tube with ENFit connector, 20FR
20888277411057Gastrostomy Tube with ENFit connector, 18FR
20888277411040Gastrostomy Tube with ENFit connector, 16FR
20888277411033Gastrostomy Tube with ENFit connector, 14FR

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