Mechanical positive pressure airway secretion-clearing device - India CDSCO Medical Device Registration

Mechanical positive pressure airway secretion-clearing device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000553_6b217396b2d5ea7770caba83322340db_a61b365128e92a08764bbc210efab07b. 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

Mechanical positive pressure airway secretion-clearing device

UID: IMP/MD/2023/000553_6b217396b2d5ea7770caba83322340db_a61b365128e92a08764bbc210efab07b

Brand Name

OmniLab Advanced +

License Holder

PHILIPS INDIA LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Philips Respironics CoughAssist E70 device assists patients in loosening, mobilizing, and clearing secretions by providing high frequency oscillatory vibrations while gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. The oscillatory vibrations assist in loosening and mobilizing the secretions while the rapid shift in pressure produces a high expiratory flow rate from the lungs, which promotes the clearance of secretions. The CoughAssist E70 device may be used either with a facemask or mouthpiece, or with an adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough. The CoughAssist E70 device is for use in a hospital, institutional environment, or in the home