| Primary Device ID | 10860000931301 |
| NIH Device Record Key | 04bfc595-55c8-40cd-8076-2dddf741bdff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gabriel Feeding Tube with Balloon |
| Version Model Number | 8 Fr |
| Catalog Number | GFTB 408 |
| Company DUNS | 001058887 |
| Company Name | SYNCRO MEDICAL INNOVATIONS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)980-9159 |
| sabrygabriel@syncromedical.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000931304 [Primary] |
| GS1 | 10860000931301 [Package] Contains: 00860000931304 Package: Box [10 Units] In Commercial Distribution |
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2019-01-24 |
| 10860000931325 | Preassembeled with Stylet |
| 10860000931318 | Preassembeled with Stylet |
| 10860000931301 | Preassembeled with Stylet |
| 10860000931356 | and EnFit Connector |
| 10860000931349 | and EnFit Connector |
| 10860000931332 | and EnFit Connector |