The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon dioxide gas exchange to occur by diffusion across a polymethylpentene (PMP) hollow fibre membrane…
The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon dioxide gas exchange to occur by diffusion across a polymethylpentene (PMP) hollow fibre membrane material. Used in conjunction with a heart-lung machine along with a separate venous reservoir and heat exchanger, the sLA Membrane Lung can be used in open-heart surgery.
Who Else Makes It
Registered in Guangdong.
Record
Regulatory record for sLA Membrane Lung | Listed by | Novalung GmbH, United States |
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Record published | 2015-09-30 |
| Record revised | 2020-02-13 (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 |
| Storage | Storage environment temperature 50 to 86 °F |
| Distribution end date | 2018-12-31 |
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.