QLN — Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19 Class N
FDA product code QLN covers "Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QLN
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
Definition
to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.