| Primary Device ID | 10810000526182 |
| NIH Device Record Key | 8998d10e-f5f2-40a4-a1ad-c8172f3ec98e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TriPhasix™ |
| Version Model Number | S403 |
| Catalog Number | S403 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 2 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| 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 |