Product code QWF

Device name

Tubing, Long Term Support Greater Than 6 Hours

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.4100

Review panel

CV

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.

Source

FDA openFDA device classification dataset