CDSCO UID IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_2a617113f4f322f120dd7310d118d37b

Ventilator

PHILIPS INDIA LIMITED·Device Class Class C·India CDSCO·Brand: BiPAP A40
Registration details
UID
IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_2a617113f4f322f120dd7310d118d37b
Device class
Class C
Brand name
BiPAP A40
License holder
PHILIPS INDIA LIMITED
Approving authority
CDSCO
Product information
The BiPAP A40 EFL ventilator is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (BiPAP A40) with Obstructive Sleep Apnea (BiPAP A40) or Respiratory Insufficiency. It is intended to be used within the home, institutional/hospital, and diagnostic laboratory environments. This device is not intended for life support. It is not intended to be used as a transport ventilator. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (BiPAP A40) with Obstructive Sleep Apnea (BiPAP A40), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (BiPAP A40) to screen for the presence, and abolishment of Expiratory Flow Limitation
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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_2a617113f4f322f120dd7310d118d37b. 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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