Airgle

Basic Information

• Brand Name: Airgle
• Primary DI: 00860013509972
• Version / Model: AF600HC
• Company Name: Airgle Corporation
• Labeler DUNS: 070692212
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-28
• Public Version: 1
• Public Version Date: 2025-07-07
• Public Version Status: New
• Public Device Record Key: 17669d5b-6186-4bd4-adef-ae71baabd2a4

Device Description

This cHEPA and Gas & Odor Filter set is a replacement accessory for AG600, covered under AG600's 510(k) K232645. It does not have a separate 510(k).

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: Yes
• 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	00860013509972	GS1

Customer Contacts

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