BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RGF-BioControls

    DI: 00811095020060 · Model: MUS-400-002 · RGF ENVIRONMENTAL GROUP, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RGF-BioControls
    Primary DI
    00811095020060
    Version / Model
    MUS-400-002
    Company Name
    RGF ENVIRONMENTAL GROUP, INC.
    Labeler DUNS
    804797439
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-09
    Public Version
    1
    Public Version Date
    2020-03-17
    Public Version Status
    New
    Public Device Record Key
    f6b72e4f-6660-4c6d-8c10-94e20b49358a

    Device Description

    Microcon MAP400 Air Purification Unit with UV Lamps for IsoPort - 220V

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRA Purifier, Air, Ultraviolet, Medical

    GMDN Terms

    Code Name
    18113 High-efficiency filter air cleaner, mobile

    Identifiers

    Type ID
    Primary 00811095020060

    Premarket Submissions

    Submission Number Supplement Number
    K972064 000