| Primary Device ID | 08051160301249 |
| NIH Device Record Key | 6cff5748-f4f0-4567-a21e-f83b802b47b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 - PL |
| Version Model Number | HX32W-C4 |
| Company DUNS | 436188505 |
| Company Name | QURA SRL |
| Device Count | 1 |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |