FDA.reportPublic FDA data

Alzair

Primary DI
00370914030012
Brand
Alzair
Company
HUDSON SCIENTIFIC, LLC
Model
Allergy Blocker
Catalog number
50131
Device description
Alzair is a natural powder product that works by strengthening one's resistance to allergens via a nasal spray with a patented delivery system.
Published
2017-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUPCream, Nasal, Topical, Mechanical Allergen Particle Barrier

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUPCream, Nasal, Topical, Mechanical Allergen Particle BarrierGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170848000Alzair Allergy BlockerNasaleze International, Ltd.2017-06-14NUP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10370914030019PackageGS112In Commercial Distribution
20370914030016PackageGS1504In Commercial Distribution
00370914030012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037091403001910370914030019
2037091403001620370914030016
00370914030012003709140300123709140300120370914030012

GMDN Terms#

Term, Definition table
TermDefinition
Nasal air filter, topicalA non-sterile substance (e.g., a solution, spray, cream, gel, or powder) intended to be applied by a patient in or around the nasal passages to create a barrier for airborne contaminants/irritants (e.g., allergens, bacteria, viruses) to protect the nasal passages from exposure and/or to minimize their inhalation. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight800Milligram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5172124047angela.powell@hudsci.com

Regulatory Flags#

DUNS number
080339637
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370914012001CycloTens Starter Pak50053A2017-07-24
00370914001005D-Care50001A2017-07-24
00370914003054D-Care50003A2017-07-24
00370914006017D-Care50002A2017-07-24
20370914012005CycloTens Starter Pak50053A2017-07-24
00370914013015CycloTens Refill Pak50054A2017-07-24
20370914001009D-Care50001A2017-07-24
20370914013019CycloTens Refill Pak50054A2017-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00300450141019ZYRTECKenvue Brands LLCNUP2026-05-29
00300450141026ZYRTECKenvue Brands LLCNUP2026-05-29
00368093000001AllerBlock-AdultWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
00368093000025Allerblock- TravelWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
10368093000008AllerBlock-AdultWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
10368093000022Allerblock- TravelWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01