PZE

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Product code

PZE

Device name

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.

Definition text from the FDA device classification database (U.S. federal government work, public domain).