Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - CPAP/BiPAP nasal mask, reusable
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
3418 Midcourt #114
Carrollton, TX, 75006
United States Of America
1. CPAP/BiPAP nasal mask, reusable
Single Device Product
57815 CPAP/BiPAP nasal mask, reusable
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.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:52:57 AEDT
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