Product code QLO

Device name

Immunoadsorption Column For Emergency Use

Medical specialty

Unknown

Device class

N

Review panel

GU

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Extracorporeal carbon dioxide removal from blood for use during declared public health emergency.

Source

FDA openFDA device classification dataset