FDA.reportPublic FDA data

Molekule Air Mini

Primary DI
00818701020520
Brand
Molekule Air Mini
Company
MOLEKULE, INC.
Model
MN1B-US
Device description
The Molekule Air Mini 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
2021-02-25
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
K202339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202339000Molekule Air Mini, Molekule Air Mini +Molekule, Inc.2021-02-23FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818701020520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818701020520008187010205208187010205200818701020520

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet disinfection lightAn electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation. It may take various forms including a tubular bulb or a mounted unit containing the light source, and may include automatic motion sensors or timers, but does not include a user control unit or radiometers. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
00818701020537Molekule Air Mini +MN1P-US2021-02-25
00818701020544Molekule Air Mini + RetailMN1P-US Retail2021-02-25
00818701020308MolekuleAir Pro RX2020-10-14

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
00818701020537Molekule Air Mini +MOLEKULE, INC.FRA2021-02-25
00818701020544Molekule Air Mini + RetailMOLEKULE, INC.FRA2021-02-25
00818701020308MolekuleMOLEKULE, INC.FRA2020-10-14