Healthcare Industry News:  ventilator 

Devices FDA

 News Release - December 17, 2007

PARI Hydrate Receives FDA Clearance

MIDLOTHIAN, Va., Dec. 17 (HSMN NewsFeed) -- PARI Hydrate, a novel medical humidifier, received 510(k) clearance from the U.S. Food and Drug Administration (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.

About PARI Hydrate

PARI Hydrate uses novel technology to allow clinicians to independently adjust heat and humidification. It also greatly reduces rainout and cooling, because there are no heated wires or bulky tubes. Immediate applications include use with high flow gas delivered via nasal cannula, mechanical ventilation, and tracheotomies. PARI Hydrate with C-Force Technology allows clinicians to monitor, control, and customize temperature and humidity for their patients. Hydrate uses CFV technology that is licensed from Vapore, Inc. (www.vapore.com). Additional information on PARI Hydrate is online at www.parihydrate.com.

About PARI Innovative Manufacturers

PARI Innovative Manufacturers designs and manufactures products for respiratory care that uniquely meet a clinical need identified by evidence- based medicine. PARI Innovative Manufacturers is part of the PARI group of companies with a North American office in Midlothian, VA and worldwide headquarters in Munich, Germany. PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. Online at www.pari.com



Source: PARI Innovative Manufacturers

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