BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Integrated Medical Specialties

    DI: 20868564000065 · Model: IMS010 · INTEGRATED MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    Integrated Medical Specialties
    Primary DI
    20868564000065
    Version / Model
    IMS010
    Company Name
    INTEGRATED MEDICAL SYSTEMS, INC.
    Labeler DUNS
    962364444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2017-03-17
    Public Version
    4
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    3d30781f-49ce-4b6e-b1cd-3c7b1bbf0357

    Device Description

    IV ADMIN SET,10 DROPS/ML, DISTAL Y-SITE

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    58977 Basic intravenous administration set, noninvasive

    Identifiers

    Type ID
    Primary 20868564000065
    Unit of Use 00868564000061