Suction system regulator, surgical

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

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Доступна з:
LivaNova Australia Pty Ltd
Клас:
Class IIa
Статус Авторизація:
Included
Кількість Авторизація:
322411

Public Summary

Summary for ARTG Entry:

322411

LivaNova Australia Pty Ltd - Suction system regulator, surgical

ARTG entry for

Medical Device Included Class IIa

Sponsor

LivaNova Australia Pty Ltd

Postal Address

16 - 18 Hydrive Close,South Dandenong, VIC, 3175

Australia

ARTG Start Date

28/08/2019

Product category

Medical Device Class IIa

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

Ohio Medical LLC

1111 Lakeside Drive

, Gurnee Illinois, 60031

United States Of America

Products

1. Suction system regulator, surgical

Product Type

Single Device Product

Effective date

28/08/2019

GMDN

44809 Suction system regulator, surgical

Intended purpose

Vacuum Regulator used to control the high degree of negative pressure applied during surgical

applications. The Regulator includes a pressure regulating mechanism and pressure adjusting controls, it

is connected to a central vacuum system and used for the removal of secretions during surgical

procedures.

Specific Conditions

© 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 02.11.2019 at 05:50:03 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

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