Bair

Main information

  • Trade name:
  • Bair Hugger® Temperature Management System - Convection blood/fluid warming set
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bair Hugger® Temperature Management System - Convection blood/fluid warming set
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219152
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219152

3M Australia Pty Ltd - Bair Hugger® Temperature Management System - Convection blood/fluid warming

ARTG entry for

Medical Device Included Class IIb

Sponsor

3M Australia Pty Ltd

Postal Address

Locked Bag 19,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

13/01/2014

Product category

Medical Device Class IIb

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

3M Health Care Group

2510 Conway Avenue St Paul

, Minnesota, 55144

United States Of America

Products

1. Bair Hugger® Temperature Management System - Convection blood/fluid warming set

Product Type

Medical device system

Effective date

13/01/2014

GMDN

47619 Convection blood/fluid warming set

Intended purpose

The Bair Hugger 241 blood/fluid warming set is intended to warm fluids that are being infused to a patient.

The warming set is used together with a Bair Hugger 500 or 700 series warming unit.

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 08:21:11 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