Emergency

Main information

  • Trade name:
  • Emergency kit, resuscitation, general-purpose
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Emergency kit, resuscitation, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219428
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219428

Cynergex Group Pty Ltd - Emergency kit, resuscitation, general-purpose

ARTG entry for

Medical Device Included Class IIb

Sponsor

Cynergex Group Pty Ltd

Postal Address

37/2 Chaplin Drive,LANE COVE, NSW, 2066

Australia

ARTG Start Date

21/01/2014

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

Cynergex Group Pty Ltd

37/2 Chaplin Drive

LANE COVE, NSW, 2066

Australia

Products

1. Emergency kit, resuscitation, general-purpose

Product Type

Procedure Pack

Effective date

21/01/2014

GMDN

36690 Emergency kit, resuscitation, general-purpose

Intended purpose

To provide medical and dental surgeries, clinics and pre-hospital medical care providers with a bag

containing a comprehensive suite of emergency items including airway management devices, airway

tubes, resuscitators, face masks, oxygen therapy masks, nasal prongs, bandages and dressings and

monitoring equipment for immediate use in medical emergencies including cardiac and respiratory arrests,

stroke, abdominal conditions and haemorrhage. This device does not contain medications.

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 07:36:08 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

9-11-2018

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28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

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12-9-2018

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FDA - U.S. Food and Drug Administration

10-9-2018

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FDA - U.S. Food and Drug Administration

29-8-2018

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16-8-2018

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FDA - U.S. Food and Drug Administration

10-7-2018

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FDA - U.S. Food and Drug Administration

14-2-2018

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FDA - U.S. Food and Drug Administration

22-9-2016

Manufacturers and wholesale distributors must be contactable outside opening hours

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The Danish Medicines Agency will make calls to companies' main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.

Danish Medicines Agency

8-8-2016

Efficacy of emergency contraception may be reduced when taken with other medicines

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Use the clock change this Sunday as a reminder to check your emergency supplies!  http://goo.gl/aasVQ  #clocksstocks @GetReadypic.twitter.com/sHD5vhCeEu

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

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Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration