Easy

Main information

  • Trade name:
  • Easy Pump II - Elastomeric infusion pump system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Easy Pump II - Elastomeric infusion pump system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221448
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221448

B Braun Australia Pty Ltd - Easy Pump II - Elastomeric infusion pump system

ARTG entry for

Medical Device Included Class IIb

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

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

B Braun Melsungen AG

Carl Braun Strasse 1

Melsungen, , 34212

Germany

Products

1. Easy Pump II - Elastomeric infusion pump system

Product Type

Medical device system

Effective date

19/03/2014

GMDN

46542 Elastomeric infusion pump system

Intended purpose

Disposable Elastomeric Infusion Pump System

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 22.11.2017 at 11:26:56 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

31-8-2018

Public Notification: Easy 2 Slim contains hidden drug ingredient

Public Notification: Easy 2 Slim contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Easy 2 Slim, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

8-6-2015

Many addictive drugs lacked statutory packaging seal

Many addictive drugs lacked statutory packaging seal

The Danish Health and Medicines Authority’s laboratory has made a thorough investigation and found that 70 of 229 addictive drugs in the Danish market lacked the statutory packaging seal on the outer packaging. The seal makes it easy to determine whether the package has been broken before it reaches the end user. The aim is to prevent abuse.

Danish Medicines Agency

There are no news related to this product.