FDA.reportPublic FDA data

RGF-BioControls

Primary DI
00811095020183
Brand
RGF-BioControls
Company
RGF ENVIRONMENTAL GROUP, INC.
Model
WMP-003
Device description
WallMAP PC Portable Unit 220V
Published
2020-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRFCleaner, Air, Medical Recirculating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRFCleaner, Air, Medical RecirculatingGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974682000MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAPBiological Controls, Inc.1998-01-23FRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811095020183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811095020183008110950201838110950201830811095020183

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
804797439
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811095020015RGF-BioControlsMS-4002020-03-09
00811095020022RGF-BioControlsMS-400-0022020-03-09
00811095020039RGF-BioControlsMU-4002020-03-09
00811095020046RGF-BioControlsMU-400-0022020-03-09
00811095020053RGF-BioControlsMUS-4002020-03-09
00811095020060RGF-BioControlsMUS-400-0022020-03-09
00811095020077RGF-BioControlsMS-8002020-03-09
00811095020084RGF-BioControlsMS-800-0022020-03-09
00811095020091RGF-BioControlsMU-8002020-03-09
00811095020107RGF-BioControlsMU-800-0022020-03-09
00811095020114RGF-BioControlsMUS-8002020-03-09
00811095020121RGF-BioControlsMUS-800-0022020-03-09
00811095020138RGF-BioControlsEXC72020-03-09
00811095020145RGF-BioControlsEXC7-UV2020-03-09
00811095020152RGF-BioControlsWM-0022020-03-09
00811095020169RGF-BioControlsWM-0032020-03-09
00811095020176RGF-BioControlsWMP-0022020-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350128750015Airsonett AIR-4Airsonett ABFRF2023-02-01
07350128750022Airsonett AIR-4 A-1100Airsonett ABFRF2023-02-01
07290018896235SU-VEIDANGIE TECHNOLOGIES LTDFRF2021-05-23
00863342000318DefenderHealth Mor At Home CbpFRF2021-03-11
00811095020015RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020022RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020077RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020084RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020138RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020152RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020169RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020176RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00818261022019HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-02-26
00818261022903HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-29
00818261023207HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-29
00818261023504HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-29
00818261021104HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261021401HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261021708HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261022002HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261022309HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261022606HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00680418000009TRI-KLEENTRI-DIM FILTER CORPORATIONFRF2018-09-05
00680418000016TRI-KLEENTRI-DIM FILTER CORPORATIONFRF2018-09-05
00818261020510Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020534Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020640Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020817Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020893Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261021012Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12