| Primary Device ID | 18051160303066 |
| NIH Device Record Key | 9110b288-44a1-4579-932c-cd731b8126b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum SuperPAC CPB - 1/2 Venous |
| Version Model Number | SPC200A-D1 |
| Company DUNS | 436188505 |
| Company Name | SPECTRUM MEDICAL SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18051160303066 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2025-09-22 |
| 18051160303264 - Quantum SuperPAC CP Support U - High Flow | 2026-01-07 |
| 18051160303271 - Quantum SuperPAC CP Support U- Low Flow | 2026-01-07 |
| 18051160303295 - Quantum SuperPAC Cardioplegia - Master Follower | 2026-01-07 |
| 18051160303301 - Quantum SuperPAC Cardioplegia - Quick System | 2026-01-07 |
| 18051160303318 - Quantum SuperPAC Cardioplegia - Clamp System | 2026-01-07 |
| 18051160302236 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 W | 2025-12-31 |
| 18051160302274 - Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W | 2025-12-31 |
| 18051160303066 - Quantum SuperPAC CPB - 1/2 Venous | 2025-09-30 |
| 18051160303066 - Quantum SuperPAC CPB - 1/2 Venous | 2025-09-30 |