Ventilator

Main information

  • Trade name:
  • Ventilator, transportable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ventilator, transportable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221469
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221469

USL Medical Pty Ltd - Ventilator, transportable

ARTG entry for

Medical Device Included Class IIb

Sponsor

USL Medical Pty Ltd

Postal Address

PO Box 1664,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

19/03/2014

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

Weinmann Emergency Medical Technology

GmbH Co KG

Frohboese Strasses 12

, Hamburg, 22525

Germany

Products

1. Ventilator, transportable

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

36289 Transport electric ventilator

Intended purpose

The Weinmann family of emergency and transport ventilators are intended to provide ventilation for

patients requiring emergency medical care or primary care during transport in emergency rescue vehicles

or in aircraft, in accident and emergency departments, in the recovery room and when moving ventilated

patients intrahospital.

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 12:57:42 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

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