AccessGUDID - DEVICE: Alzair (00370914030012)

GUDID

Device Identifier (DI) Information

Brand Name: Alzair
Version or Model: Allergy Blocker
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 50131
Company Name: HUDSON SCIENTIFIC, LLC

Primary DI Number: 00370914030012
Issuing Agency: GS1
Commercial Distribution End Date: September 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080339637 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NUP	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170848	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 800 Milligram

Device Record Status

Public Device Record Key: 03195c53-1fa0-456c-a47c-ea0b6572db63
Public Version Date: September 19, 2022
Public Version Number: 4
DI Record Publish Date: September 19, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20370914030016	504	00370914030012	2022-09-19	Not in Commercial Distribution	Case
10370914030019	12	00370914030012	2022-09-19	Not in Commercial Distribution	Inner Pack