BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ROSC-U Head Stabilizer

    DI: 00860000876261 · Model: A02-55-135 · RESUSCITATION INTERNATIONAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ROSC-U Head Stabilizer
    Primary DI
    00860000876261
    Version / Model
    A02-55-135
    Catalog Number
    A02-55-135
    Company Name
    RESUSCITATION INTERNATIONAL, LLC
    Labeler DUNS
    053006828
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-13
    Public Version
    1
    Public Version Date
    2019-12-23
    Public Version Status
    New
    Public Device Record Key
    d45df803-4b12-4cff-ae9c-09e183b66cab

    Device Description

    Head Stabilizer used to limit head movement during resuscitation

    Device Characteristics

    Single Use
    Yes
    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
    No
    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
    DRM Compressor, Cardiac, External

    GMDN Terms

    Code Name
    61908 Cardiac resuscitator, battery-powered

    Identifiers

    Type ID
    Primary 00860000876261