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U.S. Department of Health and Human Services

Product Classification

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Device combination compression/decompression manual chest pump with impedance respiratory valve
Definition Intended for use as a cpr adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
Physical State The device system is comprised of two components: A manual pump containing a suction cup so that active decompression can take place. The valve is inserted in the respiratory circuit (e.g., facemask or advanced airway) during CPR.
Technical Method Uses active compression and decompression of the victim's chest during manual CPR, as well as impeding the inflow of air during the decompression phase to reduce the intrathoracic pressure and increase blood flow.
Target Area The pump is placed on the victim's chest, and the valve is placed within the respiratory circuit.
Review Panel Cardiovascular
Product CodePIZ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible