Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are…
Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature.
Who Else Makes It
Registered in Guangdong.
Record
Regulatory record for Quadrox-i | Listed by | Maquet Cardiopulmonary GmbH, Germany |
| FDA product code | GOD |
| Device type | Antigens, Cf (Including Cf Control), Adenovirus 1-33 |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3020 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K132166 |
| Record published | 2017-03-13 |
| Record revised | 2020-06-16 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Total volume 335 ml; weight 2.93 kg |
| Distribution end date | 2020-06-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.