airgle.comAirgle Room Air Purifier
Airgle Corporation
AIRGLE CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3030650766 | 3030650766 | AIRGLE CORPORATION | 1 | Y | 2026-01-01 | 1170 Lincoln Avenue Unit 2 Holbrook NY US 11741 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860013509903 | Airgle - The Airgle Room Air Purifier AG300 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 BacteriophageTest Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG300: >4.0 log reduction / 120 minutes | (866) 501-7750 | support@airgle.com |
| 00860013509910 | Airgle - The Airgle Room Air Purifier AG600 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 BacteriophageTest Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG600: >4.0 log reduction / 120 minutes | (866) 501-7750 | support@airgle.com |
| 00860013509927 | Airgle - 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 BacteriophageTest Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG900: >4.0 log reduction / 120 minutes | (866) 501-7750 | support@airgle.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 326547 | 1950157972 | K232645 | Airgle Room Air Purifier | FRA | 2024-02-16 |
| 326547 | 1844917783 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FRA | 1 | 2024-02-16 |
PMN#
GUDID#
Airgle - This cHEPA/Carbon Filter and Titanium Pro UV module set is a replacement accessory for AG300, covered under AG300's 510(k) K232645. It does not have a separate 510(k).
2025-06-28
Airgle - 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).
2025-06-28
Airgle - This Titanium Pro UV module is a replacement accessory for AG600, covered under AG600’s 510(k) K232645. It does not have a separate 510(k).
2025-06-28
Airgle - This cHEPA and Gas & Odor Filter set is a replacement accessory for AG900, covered under AG900's 510(k) K232645. It does not have a separate 510(k).
2025-06-28
Airgle - The Airgle Room Air Purifier AG300 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 BacteriophageTest Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG300: >4.0 log reduction / 120 minutes
2025-05-30
Airgle - The Airgle Room Air Purifier AG600 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 BacteriophageTest Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG600: >4.0 log reduction / 120 minutes
2025-05-30
Airgle - 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 BacteriophageTest Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG900: >4.0 log reduction / 120 minutes
2025-05-30
Airgle - This Titanium Pro UV module is a replacement accessory for AG900, covered under AG900’s 510(k) K232645. It does not have a separate 510(k).
2025-05-30
Airgle - 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
2025-05-30
Airgle - The Airgle Clean Room Air Purifier AG930 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): MS2Bacteriophage Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG930: >4.0 log reduction / 120 minutes
2025-05-30