Product code PKU

Device name

Insulin Pump Secondary Display

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1350

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.

Source

FDA openFDA device classification dataset