Airgle

Primary DI
00860013509941
Brand
Airgle
Company
Airgle Corporation
Model
AG700
Device description
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
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRAPurifier, Air, Ultraviolet, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRAPurifier, Air, Ultraviolet, MedicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232645000Airgle Room Air PurifierAirgle Corporation2024-02-16FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013509941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013509941008600135099418600135099410860013509941

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet-activated air cleanerAn 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 501-7750support@airgle.com

Regulatory Flags#

DUNS number
070692212
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013509965AirgleAF300HCT2025-06-28
00860013509972AirgleAF600HC2025-06-28
00860013509989AirgleAF600T2025-06-28
00860013509996AirgleAF900HC2025-06-28
00860013509903AirgleAG3002025-05-30
00860013509910AirgleAG6002025-05-30
00860013509927AirgleAG9002025-05-30
00860013509934AirgleAF900T2025-05-30
00860013509958AirgleAG9302025-05-30

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Primary DI, Brand, Company table
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