CPAP/BiPAP face mask, reusable

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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:

57814 - CPAP/BiPAP face mask, reusable

Therapeutic indications:

The Full Face Mask 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. The Full Face Mask is: ? to be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. ? 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