Summary for ARTG Entry:
Rapp Australia Pty Ltd - Oxygen cylinder regulator
ARTG entry for
Medical Device Included Class IIa
Rapp Australia Pty Ltd
PO Box 120,LARA, VIC, 3212
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.
Acare Technology Co Ltd
6F-6 No 5 Wuquan 1st Road
Xinzhuang District, New Taipei City,
Taiwan (Province of China)
1. Oxygen cylinder regulator
Single Device Product
43438 Oxygen cylinder regulator
A reduction valve designed to be attached via a pin indexed gastight connector to the valve stem of a
cylinder filled with oxygen, to reduce the cylinders high variable gas pressure (e.g., 50 - 250 bar) to a
lower, constant working pressure, typically 3 - 5 bar. It can be a single or a dual stage regulator, of a piston
or diaphragm design. It has a safety relief valve to avoid excessive pressure, it has a manometer to display
the available gas reserve of a gas cylinder, some models have an integrated flow control device to provide
controlled gas flow generally in the ranges of 0.25 lpm to 25 lpm to allow administration of oxygen therapy
or connection to a resuscitation bag (BVM). Some models also have a low pressure outlet/s, typically 4
bar, to allow the connection of gas driven devices such as, for example, a suction unit and/or ventilator.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:07:31 AEDT
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