FDA.reportPublic FDA data

Molekule

Primary DI
00818701020308
Brand
Molekule
Company
MOLEKULE, INC.
Model
Air Pro RX
Device description
The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation
Published
2020-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K200500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200500000Molekule Air Pro RXMolekule, Inc.2020-04-15FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818701020308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818701020308008187010203088187010203080818701020308

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet germicidal lightA mains electricity (AC-powered) device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation from a light source, consisting of, e.g., a low pressure mercury (Hg) vapour tube that emits ultraviolet radiation as well as visible light. It may also destroy bacteria by other means, thereby reducing concentration of airborne droplet nuclei that carry live microorganisms. It could typically be used to prevent the spreading of tuberculosis (TB).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-999-9069support@molekule.com

Regulatory Flags#

DUNS number
080508772
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006970604PurgoPM-100A2023-08-11
00818701020353Molekule Air ProSQ2P-US2021-09-02
00818701020520Molekule Air MiniMN1B-US2021-02-25
00818701020537Molekule Air Mini +MN1P-US2021-02-25
00818701020544Molekule Air Mini + RetailMN1P-US Retail2021-02-25

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
06971608312564ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
06971608312571ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
00860013509965AirgleAirgle CorporationFRA2025-06-28
00860013509972AirgleAirgle CorporationFRA2025-06-28
00860013509989AirgleAirgle CorporationFRA2025-06-28
00860013509996AirgleAirgle CorporationFRA2025-06-28
00860013509903AirgleAirgle CorporationFRA2025-05-30
00860013509910AirgleAirgle CorporationFRA2025-05-30
00860013509927AirgleAirgle CorporationFRA2025-05-30
00860013509934AirgleAirgle CorporationFRA2025-05-30
00860013509941AirgleAirgle CorporationFRA2025-05-30
00860013509958AirgleAirgle CorporationFRA2025-05-30
00860006970604PurgoMOLEKULE, INC.FRA2023-08-11
00860010611906RGSGenesis Air, Inc.FRA2023-07-18
00860010611913RGS miniGenesis Air, Inc.FRA2023-07-18
00852348007438AerobiotixAEROBIOTIX, INC.FRA2022-11-15
00852348007582AerobiotixAEROBIOTIX, INC.FRA2022-11-15
00852348007773AerobiotixAEROBIOTIX, INC.FRA2022-02-04
00852348007568AerobiotixAEROBIOTIX, INC.FRA2021-12-03
00852348007551AerobiotixAEROBIOTIX, INC.FRA2021-09-03
00818701020353Molekule Air ProMOLEKULE, INC.FRA2021-09-02
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