| Primary Device ID | 00860000931366 |
| NIH Device Record Key | 0a41ccf4-1fc5-4df0-89e8-740dd34f03df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gabriel 3-way EnFit Valve |
| Version Model Number | GEV-0001 |
| Catalog Number | GEV-0001 |
| Company DUNS | 001058887 |
| Company Name | SYNCRO MEDICAL INNOVATIONS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com | |
| Phone | (888)980-9159 |
| sabrygabriel@syncromedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000931366 [Primary] |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-15 |
| Device Publish Date | 2021-02-07 |
| 00860000931366 - Gabriel 3-way EnFit Valve | 2021-02-15 |
| 00860000931366 - Gabriel 3-way EnFit Valve | 2021-02-15 |
| 10860000931332 - Gabriel Feeding Tube with Balloon | 2020-02-26 and EnFit Connector |
| 10860000931349 - Gabriel Feeding Tube with Balloon | 2020-02-26 and EnFit Connector |
| 10860000931356 - Gabriel Feeding Tube with Balloon | 2020-02-21 and EnFit Connector |
| 10860000931301 - Gabriel Feeding Tube with Balloon | 2020-02-06 Preassembeled with Stylet |
| 10860000931318 - Gabriel Feeding Tube with Balloon | 2020-02-06 Preassembeled with Stylet |
| 10860000931325 - Gabriel Feeding Tube with Balloon | 2020-02-06 Preassembeled with Stylet |