Summary for ARTG Entry:
Flexicare Australia Pty Ltd - Connector, mouthpiece, single-use
ARTG entry for
Medical Device Included Class IIa
Flexicare Australia Pty Ltd
C/o 16 Elmstead Drive,WHEELERS HILL, VIC, 3150
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.
Flexicare Medical Ltd
Cynon Valley Business Park Mountain Ash
, Mid Glamorgan, CF45 4ER
1. Connector, mouthpiece, single-use
Single Device Product
44545 Connector, mouthpiece, single-use
To be inserted into the patient's mouth and connect, via tubing, with a therapeutic or diagnostic respiratory
device. The mouthpiece will provide a gas-tight fitting to the patient's respiratory system through the simple
insertion into the mouth and the patient closing his/her lips around it.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:38:58 AEDT
This is not an ARTG Certificate document.
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