Irrigation

Main information

  • Trade name:
  • Irrigation kit,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Irrigation kit,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217295
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217295

Care Pharmaceuticals Pty Ltd - Irrigation kit, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Care Pharmaceuticals Pty Ltd

Postal Address

PO Box 1674,BONDI JUNCTION, NSW, 1355

Australia

ARTG Start Date

14/11/2013

Product category

Medical Device Class 1

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

Tismor Health & Wellness Pty Ltd

19A Garema Circuit

KINGSGROVE, NSW, 2208

Australia

Products

1. Irrigation kit, <specify>

Product Type

Single Device Product

Effective date

14/11/2013

GMDN

15585 Irrigation kit, <specify>

Intended purpose

To cleanse or flush the nasal passages and sinus cavity with saline. Saline solution and aspirator to clear

and clean the nasal passages and sinus cavity. The solution can be self-administered for postoperative,

preventive, or symptomatic nasal care.

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 02:41:48 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