SoClean, a company pioneering bacterial reduction systems for CPAP hoses and masks, has been awarded U.S. Food and Drug Administration (FDA) de novo clearance for its SoClean 3+ device.

SoClean是CPAP软管和口罩细菌减少系统的先驱公司，其SoClean 3+设备已获得美国食品和药物管理局（FDA）的从头批准。

According to the company, SoClean 3+ is the only FDA-cleared product used as an adjunct to reduce bacterial populations on some compatible, home-use CPAP mask and ventilation hoses after cleaning. It’s been shown to achieve 99.9% bacterial reduction in CPAP hoses and masks.

据该公司称，SoClean 3+是唯一一种FDA批准的产品，用于在清洁后减少一些兼容的家用CPAP口罩和通风软管上的细菌数量。事实证明，CPAP软管和口罩的细菌减少率为99.9%。

SoClean 3+ is an over-the-counter device and can be purchased online. It’s currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for the ResMed AirSense 10 CPAP.

SoClean 3+是一种非处方设备，可以在线购买。它目前已建立用于ResMed Mirage FX（鼻罩），ResMed ClimateLine Air（管道）和ResMed AirSense 10 CPAP的SlimLine（管道）。

The company said it’s working to establish further hoses and masks for use with SoClean 3+. The company will instruct customers on how to upgrade current devices to SoClean 3+ in the next 60 days. SoClean will also offer an upgrade program to uses of any other CPAP hose and mask cleaning devices.

该公司表示，正在努力建立更多的软管和口罩，用于SoClean 3+。。SoClean还将为任何其他CPAP软管和面罩清洁设备的使用提供升级计划。

The company has more than 150 patents worldwide focused on its bacterial reduction systems, methods, devices, and designs.

该公司在全球拥有150多项专利，专注于其细菌减少系统，方法，设备和设计。

“Sleep apnea is a growing issue worldwide, which impacts user’s ability to get a proper night’s rest,” said SoClean CEO Robert Wilkins. “Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users.”

SoClean首席执行官罗伯特·威尔金斯（RobertWilkins）表示：“睡眠呼吸暂停在全球范围内是一个日益严重的问题，它会影响用户夜间适当休息的能力。”。“确保清洁后CPAP软管和口罩中的细菌可以很容易地减少，这对于用户的日常使用和维护至关重要。”