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

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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