Device
UB2
Manufacturer
M&M Pure Air Systems LLC
Model: UB2 DI: 00850040983098 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-19 Current Version: 2026-05-27 Distribution End: 2026-05-19
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: d5085714-fdaf-4fd5-8c29-c5e278bc06f2
Distribution Status: Not in Commercial Distribution
DUNS Number: 080704335
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00850040983098
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45564
Name: Nasal inhaler
Definition:
A hand-held device designed to administer medication directly into the nares of a patient, typically for the purpose of alleviating symptoms of the common cold and/or sinus ailments. It is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. This is a reusable device that must be filled prior to use and is intended for single-patient use.
FDA Product Codes
KCO
Nasal Spray, Ent Delivery