Airgle

Basic Information

• Brand Name: Airgle
• Primary DI: 00860013509927
• Version / Model: AG900
• Company Name: Airgle Corporation
• Labeler DUNS: 070692212
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-30
• Public Version: 1
• Public Version Date: 2025-06-09
• Public Version Status: New
• Public Device Record Key: 948ee592-0db8-4b65-81e5-b76e1376d60f

Device Description

The Airgle Clean Room Air Purifier AG900 is a free-standing air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254 nm), intended for the inactivation of indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to be effective against MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure and operating conditions: Test Item(s): MS2 Bacteriophage Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG900: >4.0 log reduction / 120 minutes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	880.6500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65418	Ultraviolet-activated air cleaner	An air purification device intended to destroy airborne pathogens and pollutants (e.g., volatile organic compounds) in the ambient air of an enclosed room/area using ultraviolet (UV) radiation light applied to the air before being ventilated/recirculated to the room. It consists of an electrically-powered unit with an enclosed optic chamber in which air is exposed to UV energy whereby disinfection is achieved through hydroxyl radicals (produced by the reaction between UV energy and water vapour), or by a UV-activated photocatalyst (e.g., titanium dioxide). It may be a floor-standing device or a unit integrated into the facility ventilation system, and may include air filters (e.g., HEPA).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013509927	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232645	000