Product code QJY

Device name

Infusion Pump, Drug Specific, Pharmacy-Filled

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

A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

Source

FDA openFDA device classification dataset