BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MaxFlo2

    DI: 00853061006050 · Model: R223P01-003 · MAXTEC, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MaxFlo2
    Primary DI
    00853061006050
    Version / Model
    R223P01-003
    Company Name
    MAXTEC, LLC
    Labeler DUNS
    169911828
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-14
    Public Version
    2
    Public Version Date
    2019-05-07
    Public Version Status
    Update
    Public Device Record Key
    893deeb6-e11c-4833-841a-5f0d1d9d434c
    Distribution End Date
    2019-05-06

    Device Description

    Low low with MaxO2+A, DISS Fitting Kit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

    GMDN Terms

    Code Name
    44225 Oxygen/air breathing gas mixer, hospital

    Identifiers

    Type ID
    Primary 00853061006050

    Premarket Submissions

    Submission Number Supplement Number
    K113232 000