Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection 70-0060-112

GUDID 10827002447803

Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube
Primary Device ID10827002447803
NIH Device Record Key8fef62e0-d45b-4e65-a969-ba16161edef7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEntuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Version Model NumberSBRD-12-ENF
Catalog Number70-0060-112
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002447806 [Primary]
GS110827002447803 [Package]
Contains: 00827002447806
Package: Case Box [10 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 Number4
Public Version Date2019-10-07
Device Publish Date2016-08-01

On-Brand Devices [Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection]

10827002447858Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 22 FR
10827002447841Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 20 FR
10827002447865Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 24 FR
10827002447834Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 18 FR
10827002447827Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR
10827002447810Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 14 FR
10827002447803Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR

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