Search Results

OmniNeb™: This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The OmniNeb™ INebulizer is a low flow continuous nebulizer to be used to deliver aerosolized medications for up to four hours via direct patient interface on spontaneous breathing patients. Patient population: Asthma, Pneumonia. COPD. or any other conditions in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized. The Omni-Neb™ requires 45-55 psig source gas of Oxygen or Air.

OmniMax™: This device is to be used under medical supervision in hospitals. The OmniMax™ Nebulizer is to be used to deliver aerosolized medications in conjunction with Heliox therapy to sponfaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized, and adjunctive Heliox would be beneficial. The Omni-Max® requires 45-55 psig of Oxygen source gas. 10 liters/minute of 80/20 Heliox is added via auxiliary gas port.

Nebulizer (Direct Patient Interface)

I apologize, but this document is a 510(k) clearance letter from the FDA for nebulizer devices (Omni-Neb and Omni-Max). It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document primarily focuses on the substantial equivalence determination for these nebulizers.

Therefore, I cannot provide the requested information based on the content of this document.

Ask a specific question about this device