Valve

Main information

  • Trade name:
  • Valve, demand
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Valve, demand
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220973
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220973

APL Group Pty Ltd - Valve, demand

ARTG entry for

Medical Device Included Class IIb

Sponsor

APL Group Pty Ltd

Postal Address

PO Box 1300,UPWEY, VIC, 3158

Australia

ARTG Start Date

11/03/2014

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

Ambulanc Shenzhen Tech Co Ltd

East 3/F Block A Nan Yuan Ind Park Xin Yuan

Road Nanshan District

Shenzhen, , 518052

China

Products

1. Valve, demand

Product Type

Single Device Product

Effective date

11/03/2014

GMDN

17169 Valve, demand

Intended purpose

The Demand Valve Resuscitator (DVR) is a device used to maintain artificial ventilation during respiratory

arrest or to provide oxygen during periods of respiratory distress.

The handheld resuscitator is lightweight, portable and can be operated on either compressed gas or

medical oxygen from either a cylinder or piped-in system. The device comes with a reusable mask.

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 02:34:39 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

17-2-2014

Danish Pharmacovigilance Update 19 December 2013

Danish Pharmacovigilance Update 19 December 2013

In this issue of Danish Pharmacovigilance Update: Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®.

Danish Medicines Agency

There are no news related to this product.