Valve

Main information

  • Trade name:
  • Valve, stopcock, general-purpose
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Valve, stopcock, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216352
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216352

Flexicare Australia Pty Ltd - Valve, stopcock, general-purpose

ARTG entry for

Medical Device Included Class Is

Sponsor

Flexicare Australia Pty Ltd

Postal Address

C/o 16 Elmstead Drive,WHEELERS HILL, VIC, 3150

Australia

ARTG Start Date

22/10/2013

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

Flexicare Medical Ltd

Cynon Valley Business Park Mountain Ash

, Mid Glamorgan, CF45 4ER

Products

1. Valve, stopcock, general-purpose

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

35375 Valve, stopcock, general-purpose

Intended purpose

To be connected to a urinary drainage catheter and to a urine collection bag to regulate the flow of urine to

the bag.

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 05:13:33 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.