Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
LivaNova Australia Pty Ltd - Suction system regulator, surgical
ARTG entry for
Medical Device Included Class IIa
LivaNova Australia Pty Ltd
16 - 18 Hydrive Close,South Dandenong, VIC, 3175
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.
Ohio Medical LLC
1111 Lakeside Drive
, Gurnee Illinois, 60031
United States Of America
1. Suction system regulator, surgical
Single Device Product
44809 Suction system regulator, surgical
Vacuum Regulator used to control the high degree of negative pressure applied during surgical
applications. The Regulator includes a pressure regulating mechanism and pressure adjusting controls, it
is connected to a central vacuum system and used for the removal of secretions during surgical
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Produced at 02.11.2019 at 05:50:03 AEDT
This is not an ARTG Certificate document.
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