FDA-Device2019-04-03Class II
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.
SANRAI INTERNATIONAL LLC
Hazard
The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
Sold states
International distribution in the country of South Africa.
Affected count
150 units
Manufactured in
1701 North St Ste 40, N/A, Endicott, NY, United States
Products
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2019Don't want to check this manually?
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