FDA.reportPublic FDA data

Medical Guardian

Primary DI
00860006514808
Brand
Medical Guardian
Company
Aerus LLC
Model
F170A
Published
2021-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K201220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201220000Aerus Medical Guardian,model F170AAerus Medical, LLC2020-06-17FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006514808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006514808008600065148088600065148080860006514808

GMDN Terms#

Term, Definition table
TermDefinition
High-efficiency filter air cleaner, mobileA mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098188469
Device count
1
Serial number
true
Manufacturing date on label
true

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
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