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    SoClean 3+ Frequently Asked Questions

    The SoClean 3+ is currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine tubing for the ResMed AirSense 10.** The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established. For the latest information about SoClean 3+, sign up for updates using the above form.

    Yes. More information about how to upgrade your devices will be forthcoming. In the meantime, you can get the most recent updates by completing the above form.

    No. The SoClean3+ was cleared as an adjunct to your CPAP manufacturer's cleaning instructions.

    No, the SoClean 3+ is an over-the-counter device. Once publicly available, it can be purchased online at www.SoClean.com.

    Since the SoClean just received de-novo clearance, units of the SoClean 3+ are not yet available. For the most up-to-date information on the SoClean 3+ product release, sign up for updates using the above form.

    Hand-washing your CPAP equipment is meant to remove organic material whereas the SoClean 3+ is intended to be used as an adjunct to hand-washing and has been demonstrated to achieve 99.9% bacterial reduction* in CPAP hoses and masks providing you with fresh equipment after each use.

    The FDA de-novo clearance is an FDA marketing authorization pathway in which a new type of low to moderate risk medical device classification is established. Obtaining de-novo clearance for the SoClean 3+ means that SoClean worked with the FDA to create a new Class II category named, "Respiratory accessory microbial reduction devices". As the only product in this category, SoClean 3+ is the sole FDA-cleared product that provides users with adjunct bacterial reduction of CPAP hoses and masks.
    For more information on the de-novo process, see the FDA's website.

    *The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established.

    The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.

    **SoClean is an independent company not affiliated with ResMed Inc. Names and associated trademarks are solely owned by the respective companies and manufacturers. Depictions of brand logos are for informational and educational purposes only and are used for customer equipment recognition.