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510(k) Data Aggregation
K Number
K134003Device Name
RHINIX NASAL FILTER
Manufacturer
RHINIX APS
Date Cleared
2014-09-04
(251 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Applicant Name (Manufacturer) :
RHINIX APS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RHINIX™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.
Device Description
The device consists of a filtering membrane/media and a frame. The filtering membrane is a planar filter made of polypropylene non-woven fibers. The frame is made of medical grade SEBS compound which is a biocompatible polymer designed for human skin contact. Each filter section in each nostril is connected via the frame's u-shaped bridge. The device is made in multiple sizes.
The device is inserted in the nostrils and is in contact with unbroken skin in the anterior vestibule of the nostrils (non-invasive). The device functions as a filtering device (mechanical barrier) that removes particles (pollen) from the inhaled air. The filter allows adequate air movement while breathing through the nose. The device is single-use and should only be used when exposed to allergens.
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