| Primary Device ID | 08051160300761 |
| NIH Device Record Key | 9e0f2115-cf3b-4641-ad0c-054e42b7cba4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 |
| Version Model Number | VT160-C2 |
| Company DUNS | 436188505 |
| Company Name | SPECTRUM MEDICAL 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 | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08051160300761 [Primary] |
| DTZ | Oxygenator, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-27 |
| Device Publish Date | 2024-11-19 |
| 08051160300709 - Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2 | 2024-11-27 |
| 08051160300761 - Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 | 2024-11-27 |
| 08051160300761 - Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 | 2024-11-27 |
| 18051160302205 - Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W | 2024-11-27 |
| 18051160302267 - Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 W | 2024-11-27 |
| 18051160301864 - Quantum Perfusion Blood Oxygenator VT75-E1 | 2024-11-13 |
| 18051160301871 - Quantum Perfusion Blood Oxygenator VT75-E2 | 2024-11-13 |
| 18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA | 2024-08-20 |
| 18051160302816 - Quantum SuperPAC Tubing set - SP07C-AA | 2024-08-20 |