Product code LBW

Device name

Set, Dialysis, Single Needle (Co-Axial Flow)

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5540

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Source

FDA openFDA device classification dataset