Infusion regulator, pressure

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

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Доступна з:
Meditech Systems Asia Pacific Pty Ltd
Клас:
Class 1
Статус Авторизація:
Included
Кількість Авторизація:
321745

Public Summary

Summary for ARTG Entry:

321745

Meditech Systems Asia Pacific Pty Ltd - Infusion regulator, pressure

ARTG entry for

Medical Device Included Class 1

Sponsor

Meditech Systems Asia Pacific Pty Ltd

Postal Address

Unit 4 71 McDonald Crescent,Bassendean, WA, 6054

Australia

ARTG Start Date

14/08/2019

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

GCMedica Enterprise Ltd Wuxi

Loujin Industrial Park Shuofang Wuxi

Jiangsu, , 214143

China

Products

1. Infusion regulator, pressure

Product Type

Single Device Product

Effective date

14/08/2019

GMDN

13100 Infusion regulator, pressure

Intended purpose

A pressure bag is used when a critically ill or injured patient requires a rapid administration of fluids or

blood products because of an emergency situation, such as low blood pressure or bleeding. The IV fluids

or blood products can be given much more quickly when a pressure bag is used. Pressure Bags are also

used for holding fluids used for transducers at a certain pressure to allow the transducer device to convert

mechanical energy into electrical energy.

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 06:57:25 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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