FDA-Device2022-10-12Class I
Philips Respironics DreamWear Full Face Mask
Philips Respironics, Inc.
Hazard
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, & District of Columbia. The countries of Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Pier, Miquel., Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Uruguay, Utd. Arab. Emir., Uzbekistan, & Zimbabwe.
Affected count
9,191,280 units
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Philips Respironics DreamWear Full Face Mask
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2022Don't want to check this manually?
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