Product code QAV

Device name

High Flow/High Velocity Humidified Oxygen Delivery Device

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.5454

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Intended to deliver high flow and/or high velocity oxygen with humidification.

Source

FDA openFDA device classification dataset