Closed-wound

Main information

  • Trade name:
  • Closed-wound drainage reservoir suction bulb
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Closed-wound drainage reservoir suction bulb
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219604
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219604

De Fries Industries Pty Ltd - Closed-wound drainage reservoir suction bulb

ARTG entry for

Medical Device Included Class Is

Sponsor

Defries Industries Pty Ltd

Postal Address

PO Box 876,NOBLE PARK, VIC, 3174

Australia

ARTG Start Date

24/01/2014

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

Degania Silicone Limited

Degania Bet

HAYARDEN, , 15130

Israel

Products

1. Closed-wound drainage reservoir suction bulb

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

45391 Closed-wound drainage reservoir suction bulb

Intended purpose

Used in conjunction with a drainage reservoir to manually create a low negative pressure in the reservoir

and the connected drain assisting in the removal of fluids or purulent material.

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 07:03:58 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

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (...

FDA - U.S. Food and Drug Administration

12-7-2018

Minimum service during 23 July - 3 August

Minimum service during 23 July - 3 August

Due to summer holidays minimum service level will be at the Icelandic Medicines Agency from 23 July till 3 August, both days included. Please note that the agency is closed on Monday 6 August due to a bank holiday.

IMA - Icelandic Medicines Agency

28-9-2017

The IMA will be closed from 11 AM on Friday

The IMA will be closed from 11 AM on Friday

The IMA will be closed from 11 AM on Friday 29 September due to a staff meeting. If necessary call +354 899 6962.

IMA - Icelandic Medicines Agency

2-6-2017

Additional Risk Minimisation Measures (aRMM)

Additional Risk Minimisation Measures (aRMM)

From 1 June 2017 IMA will take seven days to ensure that all relevant documents are enclosed in an application for aRMM evaluation. This is done to facilitate IMAs review of the material.

IMA - Icelandic Medicines Agency

29-3-2017

The IMA will be closed from noon on Friday 31 March

The IMA will be closed from noon on Friday 31 March

The IMA will be closed from noon on Friday 31 March due to a staff meeting. If necessary call +354 899 6962.

IMA - Icelandic Medicines Agency

18-12-2016

The IMA over Christmas and New Year

The IMA over Christmas and New Year

The Icelandic Medicines Agency will be closed on Monday 26 December 2016

IMA - Icelandic Medicines Agency

23-9-2016

The IMA will be closed from noon on Friday 30 September

The IMA will be closed from noon on Friday 30 September

The IMA will be closed from noon on Friday 30 September due to a staff meeting. If necessary call +354 899 6962.

IMA - Icelandic Medicines Agency

7-3-2016

The IMA will be closed from noon on Friday 11 March

The IMA will be closed from noon on Friday 11 March

The IMA will be closed from noon on Friday 11 March due to a staff meeting. If necessary call +354 899 6962.

IMA - Icelandic Medicines Agency

12-6-2015

CUG certificates for login to DKMAnet must be replaced

CUG certificates for login to DKMAnet must be replaced

The Danish Health and Medicines Authority has to replace the system used to issue Closed User Group (CUG) certificates to users of DKMAnet who cannot obtain a NemID employee certificate, i.e. primarily users employed in companies without a Danish CVR registration number. If you are currently using a CUG certificate of the old type to log in to DKMAnet, you must obtain a new certificate before 1 September 2015.

Danish Medicines Agency

15-7-2014

Changed procedure for information on duplicate closed and nullified closed cases (updated)

Changed procedure for information on duplicate closed and nullified closed cases (updated)

The new process for dispatching adverse reaction reports (ASPR) will be implemented on 12 and 13 July 2014.

Danish Medicines Agency

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

22-6-2018

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice  http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ  pic.twitter.com/wZdrU6tTzf

FDA - U.S. Food and Drug Administration