CDSCO UID IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_7e005cbbb6ab5b179957d41497d3ccd7

Ventilator

PHILIPS INDIA LIMITED·Device Class Class C·India CDSCO·Brand: BiPAP A40
Registration details
UID
IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_7e005cbbb6ab5b179957d41497d3ccd7
Device class
Class C
Brand name
BiPAP A40
License holder
PHILIPS INDIA LIMITED
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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About this record

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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