| Primary Device ID | 05060497260023 |
| NIH Device Record Key | ebb882b7-930e-49a1-8c20-b20ffdd71b2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SC+ Haemodialysis System |
| Version Model Number | SC-14354 |
| Company DUNS | 211298693 |
| Company Name | QUANTA DIALYSIS TECHNOLOGIES LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |