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:
Airway Management 3418 Midcourt #114, Carrollton, TX, 75006 United States Of America
Therapeutic area:
57815 - CPAP/BiPAP nasal mask, reusable
Therapeutic indications:
The device is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment. The device is intended for single patient adult (>66 lb/30kg) use in the home, hospital or other clinical setting.
Authorization status:
Included
