Product code
PZE: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
FDA product code · Class III · Clinical Chemistry
Key facts
| Product code | PZE |
|---|---|
| Device | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated |
| Device class | Class III |
| Review panel | Clinical Chemistry |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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… |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database