Ventilator - India CDSCO Medical Device Registration
Ventilator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_7e005cbbb6ab5b179957d41497d3ccd7. This device is marketed under the brand name BiPAP A40. The license holder is PHILIPS INDIA LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
BiPAP A40
License Holder
PHILIPS INDIA LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
The Trilogy EV300 ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy EV300 is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and noninvasive ventilation. The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Obstructive Sleep Apnea (BiPAP A40), Respiratory Insufficiency and Respiratory Failure
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