Alzair

Basic Information

• Brand Name: Alzair
• Primary DI: 00370914030012
• Version / Model: Allergy Blocker
• Catalog Number: 50131
• Company Name: HUDSON SCIENTIFIC, LLC
• Labeler DUNS: 080339637
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-19
• Public Version: 4
• Public Version Date: 2022-09-19
• Public Version Status: Update
• Public Device Record Key: 03195c53-1fa0-456c-a47c-ea0b6572db63
• Distribution End Date: 2022-09-19

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUP	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier	General Hospital	880.5045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45592	Nasal air filter, topical	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00370914030012	GS1
Package	20370914030016	GS1	Case	504	Not in Commercial Distribution	2022-09-19
Package	10370914030019	GS1	Inner Pack	12	Not in Commercial Distribution	2022-09-19

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170848	000

Device Sizes

Type	Value	Unit	Text
Weight	800	Milligram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit