FDA.reportPublic FDA data

RGF-BioControls

Primary DI
00811095020107
Brand
RGF-BioControls
Company
RGF ENVIRONMENTAL GROUP, INC.
Model
MU-800-002
Device description
Microcon MAP800 Air Purification Unit with UV Lamps - 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
FRAPurifier, Air, Ultraviolet, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRAPurifier, Air, Ultraviolet, MedicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972064000MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUVBiological Controls, Inc.1997-12-01FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811095020107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811095020107008110950201078110950201070811095020107

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
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
00811095020183RGF-BioControlsWMP-0032020-03-09

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