Airgle

GUDID 00860013509941

The Airgle Room Air Purifier AG700 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 AG700: >4.0 log reduction / 120 minutes

Airgle Corporation

Ultraviolet-activated air cleaner

• Primary Device ID: 00860013509941
• NIH Device Record Key: c0b76184-9a91-434a-b483-cb0920f7b52b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Airgle
• Version Model Number: AG700
• Company DUNS: 070692212
• Company Name: Airgle Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com
• Phone: (866) 501-7750
• Email: support@airgle.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013509941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232645

FDA Product Code

• FRA: Purifier, Air, Ultraviolet, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-09
• Device Publish Date: 2025-05-30

On-Brand Devices [Airgle]

• 00860013509958: The Airgle Clean Room Air Purifier AG930 is a free-standing air purifying device utilizing germi
• 00860013509941: The Airgle Room Air Purifier AG700 is a free-standing air purifying device utilizing germicidal
• 00860013509934: This Titanium Pro UV module is a replacement accessory for AG900, covered under AG900’s 510(k)
• 00860013509927: The Airgle Clean Room Air Purifier AG900 is a free-standing air purifying device utilizing germi
• 00860013509910: The Airgle Room Air Purifier AG600 is a free-standing air purifying device utilizing germicidal
• 00860013509903: The Airgle Room Air Purifier AG300 is a free-standing air purifying device utilizing germicidal
• 00860013509996: This cHEPA and Gas & Odor Filter set is a replacement accessory for AG900, covered under AG900's
• 00860013509989: This Titanium Pro UV module is a replacement accessory for AG600, covered under AG600’s 510(k)
• 00860013509972: This cHEPA and Gas & Odor Filter set is a replacement accessory for AG600, covered under AG600's
• 00860013509965: This cHEPA/Carbon Filter and Titanium Pro UV module set is a replacement accessory for AG300, co