| Primary Device ID | 00813939025118 |
| NIH Device Record Key | 4f4d8cec-3fda-436d-8d47-a793571984db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gastrostomy Feeding Tube with ENFit Connector |
| Version Model Number | 8884715122X |
| Catalog Number | 70-0068-112 |
| 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 | 00813939025040 [Primary] |
| GS1 | 00813939025118 [Package] Contains: 00813939025040 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 | 2018-01-16 |
| 00813939025170 | Gastrostomy Feeding Tube with ENFit Connector 24FR |
| 00813939025163 | Gastrostomy Feeding Tube with ENFit Connector 22FR |
| 00813939025156 | Gastrostomy Feeding Tube with ENFit Connector 20FR |
| 00813939025149 | Gastrostomy Feeding Tube with ENFit Connector 18FR |
| 00813939025132 | Gastrostomy Feeding Tube with ENFit Connector 16FR |
| 00813939025125 | Gastrostomy Feeding Tube with ENFit Connector 14FR |
| 00813939025118 | Gastrostomy Feeding Tube with ENFit Connector 12FR |