Summary for ARTG Entry:
Laerdal Pty Ltd - Resuscitator, pulmonary, manual, reusable
ARTG entry for
Medical Device Included Class IIa
Laerdal Pty Ltd
PO Box 52,OAKLEIGH, VIC, 3166
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.
Laerdal Medical AS
Tanke Svilangsgate 30
Stavanger, , N-4007
1. Resuscitator, pulmonary, manual, reusable
Single Device Product
17591 Resuscitator, pulmonary, manual, reusable
NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants (up to 5
kg) who require respiratory support. The NeoNatalie Resuscitator provides positive pressure ventilation of
the lungs when used with a face mask. The NeoNatalie Resuscitator may be reused provided proper
cleaning and sterilization or disinfection procedures are performed between each patient use.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:56:25 AEDT
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