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510(k) Data Aggregation
K Number
K023602Device Name
SMALL VOLUME NEBULIZER
Manufacturer
ALLEGIANCE HEALTHCARE CORPORATION
Date Cleared
2003-05-01
(185 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.
Device Description
The nebulizer is a single patient use device which is filled with a fluid, typically respiratory medication, and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.
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