| Primary Device ID | 18051160302274 |
| NIH Device Record Key | b5bfb1e6-0535-4d5c-a707-f9bc710befe3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W |
| Version Model Number | HX22V-C0W |
| 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 | 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 | 18051160302274 [Primary] |
| DTR | Heat-Exchanger, 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 | 2025-12-31 |
| Device Publish Date | 2025-12-23 |
| 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 |
| 18051160302274 - Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W | 2025-12-31 |
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| 18051160303189 - Quantum SuperPAC CPB – 3/8 Venous | 2025-09-30 |
| 18051160303196 - Quantum SuperPAC CPB – 3/8 Venous with AV Bridge | 2025-09-30 |
| 18051160303202 - Quantum SuperPAC Hybrid CPB | 2025-09-30 |
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