CPAP/BiPAP nasal mask, reusable
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-12-2017
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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIa
Manufactured by:
BMC Medical Co Ltd Room 110 Tower A Fengyu Building No 115 Fucheng Road Haidian, Beijing, 100036 China
Therapeutic area:
57815 - CPAP/BiPAP nasal mask, reusable
Therapeutic indications:
Channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system: To be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed and intended for single-patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.
Authorization status:
A
Authorization date:
2017-08-03
