| Primary Device ID | 10813939024965 |
| NIH Device Record Key | 0cac998b-ded9-463a-a641-9d6ff8b33123 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gastrostomy Tube - Dual ENFit Port (Tri-Funnel) |
| Version Model Number | VED-224 |
| Catalog Number | 70-0062-224 |
| Company DUNS | 183325125 |
| Company Name | XERIDIEM MEDICAL DEVICES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | (520) 882-7794 |
| smurray@xeridiem.com | |
| Phone | (520) 882-7794 |
| smurray@xeridiem.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813939024968 [Primary] |
| GS1 | 10813939024965 [Package] Contains: 00813939024968 Package: Case Box [5 Units] In Commercial Distribution |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-08-08 |
| 20888277411033 - Gastrostomy Tube with ENFit connector | 2020-04-20 Gastrostomy Tube with ENFit connector, 14FR |
| 20888277411040 - Gastrostomy Tube with ENFit connector | 2020-04-20 Gastrostomy Tube with ENFit connector, 16FR |
| 20888277411057 - Gastrostomy Tube with ENFit connector | 2020-04-20 Gastrostomy Tube with ENFit connector, 18FR |
| 20888277411064 - Gastrostomy Tube with ENFit connector | 2020-04-20 Gastrostomy Tube with ENFit connector, 20FR |
| 20888277411071 - Gastrostomy Tube with ENFit connector | 2020-04-20 Gastrostomy Tube with ENFit connector 22FR |
| 20888277411088 - Gastrostomy Tube with ENFit connector | 2020-04-20 Gastrostomy Tube with ENFit connector, 24FR |
| 10827002447803 - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | 2019-10-07 Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR |
| 10827002447810 - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | 2019-10-07 Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 14 FR |