BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Full Coverage Isolation Gown #RR-300FC

    DI: 00813360023042 · Model: 1 · ICP MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Full Coverage Isolation Gown #RR-300FC
    Primary DI
    00813360023042
    Version / Model
    1
    Catalog Number
    RR300FC
    Company Name
    ICP MEDICAL, LLC
    Labeler DUNS
    078780963
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-04
    Public Version
    5
    Public Version Date
    2022-10-27
    Public Version Status
    Update
    Public Device Record Key
    796d0eed-c96f-48d6-999e-e8216e8fc6e8

    Device Description

    Isolation Gown, SMS, AAMI Level 3, Full Coverage, Over the Head, Thumbloop with Elastic Wrist, Universal

    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
    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
    FYC Gown, Isolation, Surgical

    GMDN Terms

    Code Name
    61938 Surgical/examination garment kit

    Identifiers

    Type ID
    Package 20813360023046
    Package 10813360023049
    Primary 00813360023042