Product code FIF

Device name

Set, Dialysis, Single Needle With Uni-Directional Pump

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5820

Review panel

GU

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset