Swan-Ganz True Size Thermodilution Catheter model 096F6P - Catheter, cardiac, balloon, thermal dilution

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Edwards Lifesciences Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
323481

Public Summary

Summary for ARTG Entry:

323481

Edwards Lifesciences Pty Ltd - Swan-Ganz True Size Thermodilution Catheter model 096F6P - Catheter,

cardiac, balloon, thermal dilution

ARTG entry for

Medical Device Included Class III

Sponsor

Edwards Lifesciences Pty Ltd

Postal Address

PO Box 137,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

16/09/2019

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Edwards Lifesciences LLC

One Edwards Way

Irvine, California, 92614

United States Of America

Products

1. Swan-Ganz True Size Thermodilution Catheter model 096F6P - Catheter, cardiac, balloon, thermal dilution

Product Type

Single Device Product

Effective date

16/09/2019

GMDN

34925 Catheter, cardiac, balloon, thermal dilution

Functional description

The Swan-Ganz thermodilution catheter model number 096F6P provides diagnostic information to rapidly

determine haemodynamic pressures and cardiac output when used with a compatible cardiac output

computer. It is a pack of 5, has a 110cm usable length, 6 French size catheter body, diameter of inflated

balloon 11mm, thermistor, a distal lumen and an injectate lumen.

Intended purpose

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.

Variant information

Nil variant (as 1 device) 1

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 08.11.2019 at 10:37:22 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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