Burn

Main information

  • Trade name:
  • Burn wrap
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Burn wrap
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218614
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218614

Aero Healthcare - Burn wrap

ARTG entry for

Medical Device Included Class Is

Sponsor

Aero Healthcare

Postal Address

PO Box 1635,ARMIDALE, NSW, 2350

Australia

ARTG Start Date

17/12/2013

Product category

Medical Device Class Is

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

Aero Health Aust Pty Ltd T/A Australia Aero

Healthcare

63 Seaton Street

ARMIDALE, NSW, 2350

Australia

Products

1. Burn wrap

Product Type

Single Device Product

Effective date

17/12/2013

GMDN

36093 Burn wrap

Intended purpose

A sterile, trauma covering used to maintain the stability of a burn patient en route to a burn centre or

hospital. The device is intended to be applied at the emergency site and is used to prevent burn

progression, minimize trauma, and provide protection against contamination. This device may be of

various materials and sizes. This is a single use device.

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 09:52:56 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

19-11-2018

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FLIR Lorex, Inc. recalls certain Lorex Video Monitors

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