| Primary Device ID | 00867622000401 |
| NIH Device Record Key | 101feabe-07fd-4450-be32-5331f3555058 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bolink(TM) |
| Version Model Number | 1085 |
| Catalog Number | 1085 |
| Company DUNS | 080494259 |
| Company Name | U DELIVER MEDICAL L.L.C. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9522000270 |
| info@udelivermedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867622000401 [Primary] |
| GS1 | 10867622000408 [Package] Package: Carton [30 Units] In Commercial Distribution |
| GS1 | 20867622000405 [Package] Package: carton [10 Units] In Commercial Distribution |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-19 |
| 00867622000418 | Large Cap Gravity Feeding Set with ENFit Connector |
| 00867622000401 | Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector |