Infusion regulator, pressure

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Ecomed Pty Ltd
Class IIa
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


Ecomed Pty Ltd - Infusion regulator, pressure

ARTG entry for

Medical Device Included Class IIa


Ecomed Pty Ltd

Postal Address

Unit 4 / 30 Foundry Road,SEVEN HILLS, NSW, 2147


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Statcorp Medical

35301 SE Center Street

Snoqualmie, WA, 98065

United States Of America


1. Infusion regulator, pressure

Product Type

Single Device Product

Effective date



13100 Infusion regulator, pressure

Intended purpose

A device for regulating the supply of the infusion, fluid or blood, by a pressure applied to an infusion bag

inserted into this device. The pressure can be brought about by using mechanically, pneumatically

(pressurized air) or manually (hand pump) applied forces.

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

Public Summary

Page 1 of

Produced at 08.11.2019 at 10:01:03 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.

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