°M Warmer - Conduction blood/ fluid warmer

Main information

  • Trade name:
  • °M Warmer - Conduction blood/ fluid warmer
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • °M Warmer - Conduction blood/fluid warmer
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Included
  • Authorization number:
  • 313286
  • Last update:
  • 26-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

313286

HKM Group Pty Ltd - °M Warmer - Conduction blood/fluid warmer

ARTG entry for

Medical Device Included Class IIb

Sponsor

HKM Group Pty Ltd

Postal Address

PO Box 353,Underwood, QLD, 4119

Australia

ARTG Start Date

16/01/2019

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

MEQU A/S

Ole Maaloesvej 3

, Kobenhavn N, DK-2200

Denmark

Products

1. °M Warmer - Conduction blood/fluid warmer

Product Type

Medical device system

Effective date

16/01/2019

GMDN

47616 Conduction blood/fluid warmer

Intended purpose

Intended to heat up blood, blood products or infusion fluids before infusing into the bloodstream of

patients, to prevent hypothermia.

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 27.05.2019 at 02:16:41 AEST

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