| Primary Device ID | 00368135002000 |
| NIH Device Record Key | a4a86010-c3dd-4d6c-9016-f995884d2e4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brineura Administration Kit |
| Version Model Number | 71098 |
| Company DUNS | 010004135 |
| Company Name | BIOMARIN PHARMACEUTICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | true |
| 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 | false |
| OTC Over-The-Counter | false |