Portable electric ventilator - India CDSCO Medical Device Registration

Portable electric ventilator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000553_b14b60889549d9ff4cf07dda8f5c42fd_2336b5e78fb696a698db47bc00dcb5c7. This device is marketed under the brand name OmniLab Advanced + . The license holder is PHILIPS INDIA LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Portable electric ventilator

UID: IMP/MD/2023/000553_b14b60889549d9ff4cf07dda8f5c42fd_2336b5e78fb696a698db47bc00dcb5c7

Brand Name

OmniLab Advanced +

License Holder

PHILIPS INDIA LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

The OmniLab Advanced + is intended to provide non-invasive ventilation for pediatric patients 7 years or older >18.2 kg (OmniLab Advanced + ) with Respiratory Insufficiency or Obstructive Sleep Apnea (OmniLab Advanced + ). It is also intended to treat adult patients >30 kg (OmniLab Advanced + ) with Respiratory Insufficiency or Obstructive Sleep Apnea caused by central and/or mixed apneas and periodic breathing. The device is intended for use in the hospital. WARNING: The effectiveness of the A-Flex or C-Flex+ therapy features or the autoSV mode has not been established for pediatric patients at this time