Main information

  • Trade name:
  • Infusion administration set, controller
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Infusion administration set, controller
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216818
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Imaxeon Pty Ltd - Infusion administration set, controller

ARTG entry for

Medical Device Included Class IIa


Imaxeon Pty Ltd

Postal Address

PO Box 6033,SILVERWATER, NSW, 1811


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.




Phoenix Srl

Via XXV Luglio 51

Mirandola, MO, 41037



1. Infusion administration set, controller

Product Type

Single Device Product

Effective date



36244 Infusion administration set, controller

Intended purpose

The device is intended to be used in combination with infusion pump systems to allow infusion of

radiopharmaceuticals from the syringe. The syringe is filled with radiopharmaceuticals from a separate

dispenser system. The syringe is then connected to an infusion pump and an extension tube to infuse the

radiopharmaceuticals into the patient.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:10:07 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 for contact information


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