Gabriel 3-way EnFit Valve GEV-0001

GUDID 00860000931366

SYNCRO MEDICAL INNOVATIONS

ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector ENFit/non-ISO80369-standardized small-bore multichannel connector
Primary Device ID00860000931366
NIH Device Record Key0a41ccf4-1fc5-4df0-89e8-740dd34f03df
Commercial Distribution StatusIn Commercial Distribution
Brand NameGabriel 3-way EnFit Valve
Version Model NumberGEV-0001
Catalog NumberGEV-0001
Company DUNS001058887
Company NameSYNCRO MEDICAL INNOVATIONS
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com
Phone(888)980-9159
Emailsabrygabriel@syncromedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000931366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIFGastrointestinal Tubes With Enteral Specific Connectors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-07

Devices Manufactured by SYNCRO MEDICAL INNOVATIONS

00860000931366 - Gabriel 3-way EnFit Valve2021-02-15
00860000931366 - Gabriel 3-way EnFit Valve2021-02-15
10860000931332 - Gabriel Feeding Tube with Balloon2020-02-26 and EnFit Connector
10860000931349 - Gabriel Feeding Tube with Balloon2020-02-26 and EnFit Connector
10860000931356 - Gabriel Feeding Tube with Balloon2020-02-21 and EnFit Connector
10860000931301 - Gabriel Feeding Tube with Balloon2020-02-06 Preassembeled with Stylet
10860000931318 - Gabriel Feeding Tube with Balloon2020-02-06 Preassembeled with Stylet
10860000931325 - Gabriel Feeding Tube with Balloon2020-02-06 Preassembeled with Stylet
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