BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ProtectYou2

    DI: 00817365020587 · Model: PROTECTYOU2APM · MOXI ENTERPRISES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ProtectYou2
    Primary DI
    00817365020587
    Version / Model
    PROTECTYOU2APM
    Company Name
    MOXI ENTERPRISES, LLC
    Labeler DUNS
    958807575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-11
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    8dd79ead-decf-48df-ad50-6c73d5a29475

    Device Description

    PROTECTYOU2 (COVER AND BOLSTERS) FOR APM

    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
    Yes
    Has Serial Number
    No
    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
    FMW Cover, Mattress (Medical Purposes)

    GMDN Terms

    Code Name
    37455 Waterproof bed mattress cover, reusable

    Identifiers

    Type ID
    Primary 00817365020587