FDA.reportPublic FDA data

Purgo

Primary DI
00860006970604
Brand
Purgo
Company
MOLEKULE, INC.
Model
PM-100A
Device description
Purgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria, viruses, fungi, and particulate matter in air. Purgo may be used in medical facilities and commercial home healthcare environments
Published
2023-08-11
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006970604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006970604008600069706048600069706040860006970604

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet ambient disinfection lightAn electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation into the surrounding environment. It is a mounted, or self-standing device, consisting of a tubular bulb or a 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
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
00818701020308MolekuleAir Pro RX2020-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971608312564ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
06971608312571ADSGuangzhou Ajax Medical Equipment Co., Ltd.FRA2026-04-22
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00818701020537Molekule Air Mini +MOLEKULE, INC.FRA2021-02-25
00818701020544Molekule Air Mini + RetailMOLEKULE, INC.FRA2021-02-25
00818701020308MolekuleMOLEKULE, INC.FRA2020-10-14