Product code QIR

Device name

Pediatric Hemodialysis System

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5861

Review panel

GU

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.

Source

FDA openFDA device classification dataset