| Primary Device ID | 00813939024876 |
| NIH Device Record Key | a7684795-d17e-4903-9bf7-e5e1f30e7b8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) |
| Version Model Number | 70-0056-218 |
| Catalog Number | 70-0056-218 |
| 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 | 00813939024739 [Primary] |
| GS1 | 00813939024876 [Package] Contains: 00813939024739 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 |
| 00813939024760 | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 24FR |
| 00813939024890 | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 22FR |
| 00813939024883 | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 20FR |
| 00813939024876 | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 18FR |
| 00813939024869 | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 16FR |
| 00813939024845 | Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 12FR |