Australia - English - Department of Health (Therapeutic Goods Administration)

tristel pty ltd - 47243 - disinfectant, medical device, chlorine dioxide - the tristel wipes system is intended to decontaminate and disinfect non-lumened medical devices including those that cannot be fully immersed in liquid disinfectant or sterilants and cannot be sterilised by heat. the system provides high-level disinfection in less than two minutes. the tristel wipes system is not intended for use on critical medical devices which must be sterilised prior to use on a patient. effective against sars-cov-2.

Australia - English - Department of Health (Therapeutic Goods Administration)

perth scientific pty ltd - 35012 - disinfecting unit, liquid, endoscope - rapid automatic washer-disinfector using disinfectant/sterilant for washing, disinfecting, sterilizing thermolabile endoscopes.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced sterilization products australia pty ltd - 35362 - sterilization process indicator, chemical/physical - to respond with a colour change on exposure to the sterilant and to differentiate between unprocessed and processed packages of medical devices to be sterilised.

Australia - English - Department of Health (Therapeutic Goods Administration)

in vitro technologies pty ltd - 40583 - sterilizer, gas, formaldehyde - the matachana 130lf, is a low temperature steam formaldehyde sterilizer, manufactured in accordance with en14180. the purpose of the 130lf is for the sterilization of temperature sensitive materials that cannot undergo steam sterilization at 121?c and 134?c. the process utilises a 2% solution of formaldehyde, combined with steam as the sterilant, in a constant vacuum environment at either 60?c or 78?c. cycles consist of the following phases: vacuum (conditioning), sterilization (holding), desorption (devapourization), drying, and flushing (venting).

Australia - English - Department of Health (Therapeutic Goods Administration)

steris australia pty ltd - 36253 - sterilizer, liquid, cold - apparatus used to sterilize medical devices using a liquid sterilant as the sterilizing agent.

Australia - English - Department of Health (Therapeutic Goods Administration)

ecolab pty ltd - 35628 - washer, decontamination, endoscope, flexible - the device soluscope is a fully automated washer/disinfector of flexible/rigid endoscopes using the high level disinfectant sol p (artg 118778) or sol d (artg 140980). the device soluscope also acts as a washer steriliser when sterile cycle selected to process flexible/rigid endoscopes using liquid sterilant sol p (artg 122580) as the sterilising agent to inactivate microorganisms

Australia - English - Department of Health (Therapeutic Goods Administration)

bausch & lomb australia pty ltd - 13730 - sterilization container - tecomet surgical instrument cases & trays are intended to protect medical device instrumentation and to facilitate the sterilization process by allowing the sterilant penetration and air removal. when used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device in maintained until used.

Singapore - English - HSA (Health Sciences Authority)

cantel medical asia/pacific pte. ltd. - gastroenterology & urology - the renatron ii 100 series dialyzer reprocessing system is indicated for the in vitro rinsing, cleaning, testing, and delivery of proportioned renalin 100 cold sterilant solution to hollow fiber dialyzers. it is also indicated for record keeping of these functions. the renatron ii 100 series system is indicated for use only with renalin 100 cold sterilant solution.

Singapore - English - HSA (Health Sciences Authority)

cantel medical asia/pacific pte. ltd. - gastroenterology & urology - the renatron® pa 100 series dialyzer reprocessing system is indicated for the in vitro rinsing, cleaning, testing, and delivery of proportioned renalin® 100 cold sterilant solution to hollow fiber dialyzers. the renatron® pa 100 series system is indicated for use only with renalin® 100 cold sterilant solution.

Australia - English - Department of Health (Therapeutic Goods Administration)

bausch & lomb australia pty ltd - 13730 - sterilization container - surgical instrument cases & trays are intended to protect medical device instrumentation and to facilitate the sterilization process by allowing the sterilant penetration and air removal. when used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device in maintained until used.