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

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
06971608312533ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
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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00860013509941AirgleAirgle CorporationFRA2025-05-30
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00852348007582AerobiotixAEROBIOTIX USA LLCFRA2022-11-15
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00860006810108ActivePure Medical GuardianACTIVEPURE MEDICAL LLCFRA2021-05-12
00819355020218The Pyure CompanyThe Pyure Company IncFRA2021-04-12
00860006514808Medical GuardianAerus LLCFRA2021-04-01
00818701020520Molekule Air MiniMOLEKULE, INC.FRA2021-02-25
00818701020537Molekule Air Mini +MOLEKULE, INC.FRA2021-02-25
00818701020544Molekule Air Mini + RetailMOLEKULE, INC.FRA2021-02-25
00818701020308MolekuleMOLEKULE, INC.FRA2020-10-14