FDA.reportPublic FDA data

ADS

Primary DI
06971608312564
Brand
ADS
Company
Guangzhou Ajax Medical Equipment Co., Ltd.
Model
Optima 350
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K202766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202766000EOS Air CleanerGuangzhou Ajax Medical Equipment Co., Ltd.2021-06-11FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971608312564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971608312564069716083125646971608312564

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).

Regulatory Flags#

DUNS number
547897476
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971608310096ADSAJ212026-04-22
06971608310140ADSAJ272026-04-22
06971608311758ADSAJX1002026-04-22
06971608311765ADSAJX2002026-04-22
06971608311802ADSAJX3002026-04-22
06971608311819ADSAJX4002026-04-22
06971608311826ADSAJX5002026-04-22
06971608311833ADSAJX6002026-04-22
06971608311840ADSAJX7002026-04-22
06971608312533ADSThor2026-04-22
06971608312540ADSThor-s2026-04-22
06971608312557ADSEOS Extraoral Suction System2026-04-22
06971608312571ADSEOS Plus2026-04-22
06971608311505ADSACA52025-09-15
06971608310003ADSAJ102023-11-02
06971608310010ADSAJ112023-11-02
06971608310027ADSAJ122023-11-02
06971608310034ADSAJ152023-11-02
06971608310041ADSAJ162023-11-02
06971608310058ADSAJ172023-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971608312540ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
06971608312557ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
06971608312571ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
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