| Primary Device ID | 04250571300719 |
| NIH Device Record Key | e92ed0e4-efe4-47ea-b341-c7ac4edce062 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HIDREX USA |
| Version Model Number | DP450 Package HF AL |
| Catalog Number | ION17451US |
| Company DUNS | 326742426 |
| Company Name | HIDREX GmbH |
| 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 | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |