The Subsalve Oxygen Treatment Hood is a patient interface for respiratory therapies using oxygen and positive pressure. This is the only such US domestically manufactured device authorized for emergency use (EUA) by the FDA to treat respiratory distress.
The afforded technique allows clinicians to:
elevate positive airway pressure
deliver therapeutic oxygen
reduce virus aerosolization in healthcare worker environment
This is a single piece oxygen treatment hood with all soft materials for patient comfort - no rigid neck rings.
Allows patient to recline comfortably. Includes two 22mm ports for standard ventilator and respiratory circuit hoses.
Raised interior port stem to reduce backflow of sputum or other fluids.
An additional pluggable breathing/service port is included.
Latex and Silicone neck seals are available in multiple sizes. Each size fits wide range and can be trimmed for comfort.
Effective August 4th, 2020, the US FDA has authorized the Subsalve Oxygen Treatment Hood for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, and has been added to Appendix B of the FDA’s Emergency Use Authorization (EUA).
The Subsalve Oxygen Treatment Hood is a patient interface intended for helmet based Non Invasive Positive Pressure Ventilation (NIPPV) according to clinician established protocols.
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.