510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QLNNot classified

Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

Unknown
FDA source (opens on fda.gov)

QLN is the FDA product code for Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QLN
Device name
Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QLN.