Product code PKP

Device name

Immunoglobulin G (Igg) Infusion System

Medical specialty

General Hospital

Device class

2

Regulation number

880.5725

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.

Source

FDA openFDA device classification dataset