Summary for ARTG Entry:
USL Medical Pty Limited - Positive airway pressure unit, bi-level
ARTG entry for
Medical Device Included Class IIa
USL Medical Pty Ltd
PO Box 1664,NORTH SYDNEY, NSW, 2059
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.
Lowenstein Medical Technology GmbH Co Kg
, Hamburg, 22525
1. Positive airway pressure unit, bi-level
Single Device Product
36990 Positive airway pressure unit, bi-level
A valve feeds oxygen directly into the ventilation device and regulates the oxygen supply by turning off and
on as required.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:10:42 AEDT
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