Summary for ARTG Entry:
Thermo Fisher Scientific Australia Pty Ltd - Mask, aerosol
ARTG entry for
Medical Device Included Class IIa
Thermo Fisher Scientific Australia Pty Ltd
PO Box 9092,SCORESBY, VIC, 3179
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.
5701-1 South Ware Road
McAllen, TX, 78503
United States Of America
1. Mask, aerosol
Single Device Product
35142 Aerosol face mask, rebreathing
Mask like device placed over the patient's mouth and nose in cases where it is difficult to fit a conventional
Oxygen Mask and connected directly to a nebuliser, and/or a compressed air or oxygen supply to spray
liquids/medicine in aerosol form into the gases delivered to the patient's airways.
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 http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 04:42:28 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