PARI Hydrate Receives FDA Clearance
PARI Hydrate received 510(k) clearance FDA and will be marketed by PARI Innovative Manufacturers for ventilator applications. PARI Innovative Manufacturers, a leading manufacturer of aerosol nebulizers and compressors, developed the PARI Hydrate to revolutionize the way gases are heated and humidified with the aim to reduce contamination risk for patients and give clinicians greater control and understanding of humidification.
"Regulatory clearance of the PARI Hydrate allows clinicians a better way to monitor and customize conditioning of medical gases, because Hydrate is the first and only humidification system that can independently control heat and humidification of medical gases," said Norm Tiffin RRT, vice president of marketing for PARI Innovative Manufacturers. "With Hydrate, clinicians will soon have the ability to customize heat and humidification to each patient's needs."
FDA clearance for high flow gas therapy was granted previously for the Hydrate. With both high flow and ventilator applications now cleared, PARI Hydrate will be available for sale in early to mid 2008.