Product code
PIZ: Combination compression/decompression manual chest pump with impedance respiratory valve
FDA product code · Class III · Cardiovascular
Key facts
| Product code | PIZ |
|---|---|
| Device | Combination compression/decompression manual chest pump with impedance respiratory valve |
| Device class | Class III |
| Review panel | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None 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