Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
CareFusion Australia 316 Pty Ltd - Multifunction cardiac electrode, adult
ARTG entry for
Medical Device Included Class IIb
CareFusion Australia 316 Pty Ltd
PO Box 355,SEVEN HILLS, NSW, 2147
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.
Leonhard Lang Gmbh
, Innsbruck, 6020
1. Multifunction cardiac electrode, adult
Single Device Product
45806 Multifunction cardiac electrode, adult
A non-sterile electrical conductor designed to be applied to an adult patient for automatic or manual
defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of
cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals
and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s),
defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive
gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead
wires. This is a single-use device.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 02:41:21 AEDT
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