Gabriel Feeding Tube with Balloon GFTB 510

GUDID 10860000931349

and EnFit Connector

SYNCRO MEDICAL INNOVATIONS

Nasogastric feeding tube
Primary Device ID10860000931349
NIH Device Record Key5dfb4516-8816-431c-aca4-b001ff5cc5f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGabriel Feeding Tube with Balloon
Version Model Number10 Fr
Catalog NumberGFTB 510
Company DUNS001058887
Company NameSYNCRO MEDICAL INNOVATIONS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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(888)980-9159
Emailsabrygabriel@syncromedical.com

Device Dimensions

Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000931342 [Primary]
GS110860000931349 [Package]
Contains: 00860000931342
Package: 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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-26
Device Publish Date2020-02-18

On-Brand Devices [Gabriel Feeding Tube with Balloon]

10860000931325Preassembeled with Stylet
10860000931318Preassembeled with Stylet
10860000931301Preassembeled with Stylet
10860000931356and EnFit Connector
10860000931349and EnFit Connector
10860000931332and EnFit Connector

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