FDA.reportPublic FDA data

Airgle

Primary DI
00860013509996
Brand
Airgle
Company
Airgle Corporation
Model
AF900HC
Device description
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).
Published
2025-06-28
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013509996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013509996008600135099968600135099960860013509996

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
Premarket exempt
true
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
00860013509903AirgleAG3002025-05-30
00860013509910AirgleAG6002025-05-30
00860013509927AirgleAG9002025-05-30
00860013509934AirgleAF900T2025-05-30
00860013509941AirgleAG7002025-05-30
00860013509958AirgleAG9302025-05-30

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Primary DI, Brand, Company table
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06971608312571ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
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