| Device |
extracorporeal system for carbon dioxide removal for the treatment of covid-19 |
| 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. |
| Physical State |
The device looks like an ECMO system |
| Technical Method |
uses partial pressures between the circulating blood and the sweep gas to allow sufficient gas exchange to treat hypercapnia |
| Target Area |
The device is part of an extracorporeal circuit and exchanges the blood gases within the device, outside of the body while the blood is circulated in the extracorporeal circuit. |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QLN |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
|
Not Classified Reason
|
EUA - Emergency Use Authorization
|
|---|
| Submission Type |
EUA - Emergency Use Authorization
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
