Summary for ARTG Entry:
Medela Australia Pty Ltd - Suction unit, thoracic
ARTG entry for
Medical Device Included Class IIb
Medela Australia Pty Ltd
3 Arco Lane,HEATHERTON, VIC, 3202
ARTG Start Date
Medical Device Class IIb
- 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.
, Baar, 6341
1. Suction unit, thoracic
Single Device Product
36787 Suction unit, thoracic
Intended use / indications
Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases,
bodily fluids or infectious materials. Thopaz+ is indicated for all situations where chest drains
are applied ± especially for thoracic drainage in the pleural and mediastinal cavity in situations
such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury,
pleural effusion, pleural empyema or other related conditions. Thopaz+ is intended for use
on patients in appropriate care settings.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:37:35 AEDT
This is not an ARTG Certificate document.
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