Tag: CPAP Cleaner
In brief: CPAP cleaners get warnings, ZOLL eyes Vyaire’s vent biz
September 4, 2024HME News Staff
WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
The companies are:
Shenzhen Moyeah Intelligent Life Technology Co. for 10 different products, including the CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP Sanitizer Bag Ozone Disinfector C966|Latest Technology.
Natures...
CPAP cleaners get warning
September 3, 2024HME News Staff
WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
The companies are:
Shenzhen Moyeah Intelligent Life Technology Co. for 10 different products, including the CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP Sanitizer Bag Ozone Disinfector C966|Latest Technology.
Natures...
FDA grants auth to SoClean device
August 19, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has granted a marketing authorization to SoClean for its SoClean 3+ bacterial reduction device for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device. The SoClean 3+ does not replace the cleaning steps recommended by manufacturers of CPAP devices. To date, there are no FDA cleared or approved devices for cleaning, disinfecting or...
Liviliti targets CPAP cleaning pain point
October 1, 2021Liz Beaulieu, Editor
LAKE CITY, Fla. – The launch of the Healthy Hose Pro by Liviliti Health Products this summer lined up well with the increasing emphasis on cleaning sleep therapy equipment, says CEO Brian Sharpe.
The hose, which is patent pending and ISO 22196 certified, is anti-microbial and designed to eliminate and prevent 99.99% of bacteria.
“We’re still going to recommend that you wash it out with soap and water, but you’re not going to have bacteria growing inside the...
Sleep8 is bullish on cleaning market
August 27, 2021Liz Beaulieu, Editor
BRENTWOOD, Tenn. – Sleep8 is leaning on a new president and a new partnership with VGM & Associates to differentiate itself in a market that’s come under scrutiny due to a recent recall of certain Philips CPAP devices.
The company, under the leadership of President Jeff Hingher, posted a blog to its website in July emphasizing that, while its CPAP cleaning system uses ozone, it only cleans the mask, tubing and water chamber – not the CPAP device.
“I’d...
SoClean reorganizes staffing
October 14, 2020HME News Staff
PETERBOROUGH, N.H. - SoClean is reducing staff in its call centers, but it's looking to grow staff in R&D and other areas of the company, CEO Bob Wilkins has told the Monadnock Ledger Transcript. The company, citing the negative impact of the COVID-19 pandemic, has laid off 23 call center employees here and in Montana in recent weeks, according to the newspaper. Sleep centers have been restricted during the pandemic, weakening referrals for CPAP therapy, a key indicator for sales of SoClean's CPAP...
Sunset Healthcare enters CPAP cleaning market
March 30, 2020Liz Beaulieu, Editor
CHICAGO - The new Zoey CPAP cleaning device from Sunset Healthcare Solutions is the company's first foray into manufacturing a more complicated device.
Sunset Healthcare manufactures some respiratory supplies in Chicago, but it's often viewed in the HME industry as more of a distributor.
“We're actually more of a manufacturer, so it's extremely exciting to manufacture a product like this,” said PJ Ruflin, vice president of business development. “Six years ago,...
Makers of CPAP cleaning devices respond
March 6, 2020Liz Beaulieu, Editor
YARMOUTH, Maine - SoClean will cover the cost of repairs for three years “in the unlikely event” that ozone from its product damages ResMed's AirSense 10.
SoClean told its partners in a letter that if a patient uses its cleaning device with an AirSense 10 that was purchased on or after Feb. 1, the company will cover the cost to repair the CPAP device during the initial two-year warranty period “in the unlikely event the AirSense 10 shows validated damage consistent with the...
Sunset Healthcare: Meet Zoey
February 4, 2020HME News Staff
CHICAGO - Sunset Healthcare Solutions now has a stake in the CPAP cleaning market. The company announced Feb. 1 that it is now manufacturing and selling the Zoey CPAP Cleaner exclusively through the HME provider channel. “Zoey marks our investment in manufacturing and developing Sunset products for the coming generation of sleep apnea patients,” said Greg Wood, chief business development officer. “This is just the start of it.” The Zoey uses activated oxygen to clean masks,...
3B debuts CPAP cleaner
February 7, 2018HME News Staff
WINTER HAVEN, Fla. - 3B Medical has launched 3B Lumin, a cleaner for CPAP masks and supplies, it announced today. Lumin has a disinfection cycle time of five minutes, releases no ozone, and is effective against bacteria, viruses, mold and fungus, according to a press release. "We wanted to develop a product that would not damage the CPAP machine itself, and had zero risk of exposing a respiratory patient to a lung irritant," said Dr. Jose Llana, national director of sales. Lumin will be available...