CPAP/BiPAP face mask, single-use
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
23-10-2020
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Available from:
Lowenstein Medical Australia Pty Ltd
Class:
Class IIa
Manufactured by:
Lowenstein Medical Technology GmbH Co Kg Kronsaalsweg 40, Hamburg, 22525 Germany
Therapeutic area:
57813 - CPAP/BiPAP face mask, single-use
Therapeutic indications:
A non sterile, flexible, form shaped device designed to be placed over a users nose and mouth to interface with CPAP or BPAP unit to provide the respiratory tract with direct ambient air, or medical oxygen and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation.
Authorization status:
A
Authorization date:
2020-09-11
