| Primary Device ID | 00811870033742 |
| NIH Device Record Key | 2107c16b-d984-4a42-8b0c-e5a4d7641a20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CUSTOM HEALTHCARE SYSTEMS, INC |
| Version Model Number | UNC-19544 |
| Company DUNS | 175254820 |
| Company Name | CUSTOM HEALTHCARE SYSTEMS, 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 | 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 |