Conduction

Main information

  • Trade name:
  • Conduction blood/fluid warmer
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Conduction blood/fluid warmer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221178
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221178

Baxter Healthcare Pty Ltd - Conduction blood/fluid warmer

ARTG entry for

Medical Device Included Class IIa

Sponsor

Baxter Healthcare Pty Ltd

Postal Address

PO Box 88,TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

12/03/2014

Product category

Medical Device Class IIa

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

Baxter Healthcare SA

8010

Zurich, ,

Switzerland

Products

1. Conduction blood/fluid warmer

Product Type

Single Device Product

Effective date

12/03/2014

GMDN

47616 Conduction blood/fluid warmer

Intended purpose

The bag warmer is intended to be used for heating solutions such as peritoneal dialysis, blood product,

intravenous and irrigation fluids to a temperature of 37oC directly prior to use.

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 10.11.2017 at 01:48:29 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