Australien - engelsk - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Edwards Lifesciences Pty Ltd - Swan-Ganz True Size Thermodilution Catheter "S-Tip" model 151F7 -
Catheter, cardiac, balloon, thermal dilution
ARTG entry for
Medical Device Included Class III
Edwards Lifesciences Pty Ltd
PO Box 137,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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.
Edwards Lifesciences LLC
One Edwards Way
Irvine, California, 92614
United States Of America
1. Swan-Ganz True Size Thermodilution Catheter "S-Tip" model 151F7 - Catheter, cardiac, balloon, thermal
Single Device Product
34925 Catheter, cardiac, balloon, thermal dilution
The Swan-Ganz Thermodilution Catheter "S-Tip" model 151F7 provides diagnostic information to rapidly
determine haemodynamic pressures and cardiac output when used with a compatible cardiac output
computer. It has a 110cm usable length, 7 French catheter body, diameter of inflated balloon 13mm,
thermistor, a distal lumen and an injectate lumen. It is designed for femoral vein insertion only.
Swan-Ganz thermodilution catheters are indicated for the assessment of a patient's haemodynamic
condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output
determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed
venous blood for the assessment of oxygen transport balance and the calculation of derived parameters
such as oxygen consumption, oxygen utilisation coefficient, and intrapulmonary shunt fraction.
Nil variant (as 1 device) 1
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Produced at 08.11.2019 at 10:36:41 AEDT
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