Summary for ARTG Entry:
Imaxeon Pty Ltd - Infusion administration set, controller
ARTG entry for
Medical Device Included Class IIa
Imaxeon Pty Ltd
PO Box 6033,SILVERWATER, NSW, 1811
ARTG Start Date
Medical Device Class IIa
- 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.
Via XXV Luglio 51
Mirandola, MO, 41037
1. Infusion administration set, controller
Single Device Product
36244 Infusion administration set, controller
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.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:10:07 AEDT
This is not an ARTG Certificate document.
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