ResMed Masks and Accessories - Reusable - CPAP/BiPAP face mask, reusable
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
27-05-2019
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Available from:
Resmed Pty Ltd
Class:
Class I
Manufactured by:
Resmed Pty Ltd 1 Elizabeth Macarthur Drive, BELLA VISTA, NSW, 2153 Australia
Therapeutic area:
57814 - CPAP/BiPAP face mask, reusable
Therapeutic indications:
ResMed mask is intended to be used by patients who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.
Authorization status:
A
Authorization date:
2018-10-16
