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Found 8 results
510(k) Data Aggregation
K Number
K213114Device Name
BentrioTM Allergy Blocker
Manufacturer
Altamira Therapeutics, Inc.
Date Cleared
2022-06-24
(270 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bentrio™ is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, animal hair and dust mites.
Application of Bentrio™ produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
Device Description
Bentrio™ is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. Bentrio™ is free of any medication such as antihistamines or steroids and does not contain any preservatives.
The gel formulation of Bentrio™ has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. Bentrio™ is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.
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K Number
K201734Device Name
AllerBlock Junior
Manufacturer
Nasaleze International Ltd
Date Cleared
2021-03-26
(274 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllerBlock Junior is intended for use in adults and children (8 years or older) to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor environmental pollens, house dust, animal hairs, and dust mites.
Application of AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
Device Description
AllerBlock Junior is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 97%) and high quality strawberry scent (3%) which has been formulated into a micronized powder of fine particles of inert cellulose. AllerBlock Junior is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.
When the powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier -- making it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reducing the intensity of allergic rhinitis (AR) symptoms.
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K Number
K170848Device Name
Alzair Allergy Blocker
Manufacturer
Nasaleze International Ltd
Date Cleared
2017-06-14
(85 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alzair Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airbone allergens including indoor environmental pollens, house dust, animal hairs and dust mites.
Application of nasal ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
Device Description
Alzair Allergy Blocker is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 98.5%) and high quality peppermint (1.5%) which has been formulated into a micronized powder of fine particles of inert cellulose. Alzair Allergy Blocker is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.
When Alzair Allergy Blocker powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier -- making it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.
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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?
Product Code :
NUP
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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K Number
K132520Device Name
NASAL EASE ALLERGY BLOCKER
Manufacturer
HI-TECH PHARMACAL, INC.
Date Cleared
2013-12-31
(141 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nasal Ease Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs and dust mites.
Application of Nasal Ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
Device Description
Nasal Ease Allergy Blocker is composed of 100% pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC) which has been formulated into a micronized powder of fine particles of inert cellulose. Nasal Ease is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.
When Nasal Ease powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier ~ making it more difficult for inhaled allergens to come into contact with the nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.
One bottle squeeze releases around 3.2mg of powder. The maximum usual dose is around 3 puffs/day into each nostril, giving a total of 19mg/day.
The cellulose gel is considered inert and does not penetrate the dermal layer of the skin. On average, protection lasts for 4-6 hours before the gel has to be re-applied. Nasal Ease is intended for topical use and provided non-sterile.
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K Number
K120894Device Name
HAYMAX
Manufacturer
HAYMAX LIMITED
Date Cleared
2012-05-17
(55 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HayMax™ organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (i.e, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.
Device Description
HayMax™ is a drug free viscous topical nasal balm consisting of a mixture of organic beeswax and organic sunflower oil. There are three further variants: one containing organic freeze dried 200:1 Aloe Vera powder, another containing organic Lavender essential oil and the last containing organic Frankincense essential oil, all in very small quantities.
HayMax™ is used as a pollen blocker prophylaxis for seasonal allergic rhinitis caused by airborne allergens. The product is sparingly applied around the base of the nostrils with a finger, or suitable applicator, eq., cotton swab. where it acts as a mechanical barrier. It traps pollen before it reaches the nasal cavity, thus reducing pollen entering the body. If this maintains the pollen (or other airborne allergen) in a person's body below their sensitivity level then they will not react to the allergen. It is reapplied regularly as required, and after sneezing or blowing the nose. It is intended for topical use and is provided non-sterile. The balm is chemically inert to the body and nasal membranes, and is certified organic.
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K Number
K053625Device Name
NASALGUARD
Manufacturer
TRUTEK CORP
Date Cleared
2006-02-22
(56 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NasalGuard® is intended to promote alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs and dust mites.
Device Description
NasalGuard is a water-based gel consisting of common, GRAS cosmetic grade ingredients. The product is applied by finger or cotton swab to the outside of the nasal passages, around the nostrils and upper lip. NasalGuard utilizes a patented methodology that uses the cationic properties of its ingredients to create an electrostatic field that attracts and blocks airborne allergens before they enter the nasal passages. The gel is considered innocuous and does not penetrate the dermal layer of the skin. The gel is concentrated and lasts for 4-6 hours before the gel has to be reapplied. NasalGuard is intended for topical use and provided non-sterile.
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K Number
K042610Device Name
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
Manufacturer
DR. THEISS NATURWAREN GMBH
Date Cleared
2005-05-16
(234 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Product Code :
NUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alergol Pollen Blocker Cream is intended to promote alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs, and dust mites.
Device Description
Alergol Pollen Blocker Cream is a viscous topical nasal cream consisting of highly refined aliphatic long-chain hydrocarbons for prophylaxis and therapy of allergic rhinitis caused by airborne allergens. The product is applied by finger or cotton swab to the inside surface of the nasal vestibule in the region of the nose flap where it acts as a mechanical barrier to reduce the adverse effects of inhaled allergens. Proper application of the cream makes it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reduces the intensity of allergic rhinitis symptoms.
The hydrocarbon gel is chemically inert to the body and nasal membranes, and contains no additives. On average, protection lasts for 3 to 5 hours before the cream has to be reapplied. The Alergol Pollen Blocker cream is intended for topical use and provided non-sterile.
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