Perfadex

Main information

  • Trade name:
  • Perfadex solution - Organ preservation solution
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Perfadex solution - Organ preservation solution
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217545
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217545

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Perfadex solution - Organ preservation solution

ARTG entry for

Medical Device Included Class III

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

20/11/2013

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

Xvivo Perfusion AB

Massans gata 10

, Goteborg, SE-412 51

Sweden

Products

1. Perfadex solution - Organ preservation solution

Product Type

Single Device Product

Effective date

20/11/2013

GMDN

18004 Organ preservation solution

Functional description

Perfadex solution for organ perfusion is a clear, sterile, non-pyrogenic colloid based extracellular low

potassium dextran solution primarily for rapid cooling, perfusion and storage of lungs in connection with

transplantation

Intended purpose

Intended for flushing, storage and transportation of isolated lungs after removal from the donor in

preparation for eventual transplantation into a recipient

Variant information

Nil variant (as 1 device) Nil

Specific Conditions

No Specific Conditions included on Record

© 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 02.12.2017 at 04:54:49 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