| Primary Device ID | 18051160302175 |
| NIH Device Record Key | 7fb5a728-bc53-4906-bae6-a71f237a58e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M |
| Version Model Number | HX11W-S2M |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18051160302175 [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 | 2023-05-12 |
| Device Publish Date | 2023-05-04 |
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| 18051160302144 - Quantum Perfusion Centrifugal Blood Pump CP20 | 2023-07-05 |
| 18051160302151 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 | 2023-05-12 |
| 18051160302168 - Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M | 2023-05-12 |
| 18051160302175 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M | 2023-05-12 |
| 18051160302175 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M | 2023-05-12 |
| 08051160301713 - Quantum Perfusion Dual Lumen Cannula 31F-VS | 2022-09-13 |
| 08051160301720 - Quantum Perfusion Dual Lumen Cannula 27F-VS | 2022-09-13 |