Surgical procedure kit, cardiothoracic, non-medicated, single-use
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
16-11-2017
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Available from:
LivaNova Australia Pty Ltd
Class:
Class IIb
Manufactured by:
LivaNova Australia Pty Ltd Unit 1 / 63 Wells Road, Chelsea Height, VIC, 3196 Australia
Therapeutic area:
46410 - Surgical procedure kit, cardiothoracic, non-medicated, single-use
Therapeutic indications:
The Custom Tubing Pack is indicated for use in cardiothoracic surgical procedures requiring extracorporeal support. The Custom Tubing Pack may consist of any or all of these devices such as oxygenators, cardiotomy reservoirs, centrifugal blood pump head, blood filters, and heat exchangers. This device is single use and non-medicated.
Authorization status:
A
Authorization date:
2009-05-19
