BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Protect U Guard Isolation Gown 20 GSM Yellow

    DI: B086205012 · Model: P20501 · PROTECT U GUARD, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    Protect U Guard Isolation Gown 20 GSM Yellow
    Primary DI
    B086205012
    Version / Model
    P20501
    Company Name
    PROTECT U GUARD, LLC
    Labeler DUNS
    080070945
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2017-02-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f4f92d11-94fd-4265-86d5-6a17b3c98d0b

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OEA Non-Surgical Isolation Gown

    GMDN Terms

    Code Name
    35492 Isolation gown, single-use

    Identifiers

    Type ID
    Primary B086205012
    Unit of Use B086205010