Full Face Mask - India CDSCO Medical Device Registration
Full Face Mask is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000241_743339abd3aebd7dc54e3b628a0c7c7a_f3a4c8adce5a4fdd96f188909aeffa06. This device is marketed under the brand name Visairo™. The license holder is Fisher & Paykel Healthcare India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Visairo™
License Holder
Fisher & Paykel Healthcare India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (Visairo™) therapy (Visairo™) to be delivered to spontaneously breathing adult patients (Visairo™) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
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