FreeMotion Hospital Masks - India CDSCO Medical Device Registration
FreeMotion Hospital Masks is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000505_553795266a9f9fb4678607252c197527_fe143301aa73db5eb4cc0aea7844d374. The license holder is Fisher & Paykel Healthcare India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
Fisher & Paykel Healthcare India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
The Fisher & Paykel FreeMotion hospital masks are patient interaces for use as accessories to therapy devices providing noninvasive bi-level or continuous positive airway pressure support therapy. The ventilator must have adequate alarms and safety systems for ventilator failure. The masks are for single patient use with spontaneously breathing adult ##PLACEHOLDER_0## patients with respiratory insufficiency or respiratory failure who are suitable for noninvasive pressure support ventilation in a hospital or clinical setting
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