HPAP kit for Non-Invasive Ventilation - Clinical Version
This Hood/Helmet+CPAP (HPAP) kit is a complete packaged set to enable helmet/hooded positive airway pressure ventilation treatment techniques.
The kit is ideally suited for settings where conventional ICU equipment may not be available, and can be used to manage large patient volumes. Includes all hardware and consumables to administer hooded/helmet ventilation according to specified protocols.
Additional sets of consumables are available.
A portion of each purchase benefits Ocean Opportunity Inc., a 501(c)3 not for profit organization committed to supporting ongoing research and education in the helmet based ventilation field.
Includes one Subsalve Oxygen Treatment Hood
Includes one continuous positive air pressure device (CPAP), optimized for helmet NIV
Includes basic patient and system monitoring
Includes oxygen titration inlet
Includes instructional line card for system use
Kit hardware plus one set of consumables fits within the supplied weatherproof case.
The US FDA has authorized the supplied primary components for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, and have been added to Appendix B of the FDA’s Emergency Use Authorization (EUA).
This device has not been FDA cleared or approved
This device has been authorized by FDA under an EUA
This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.