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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hose, Single, (Models MC2, TS3, TS4 and Lumenair for Lower Thigh And Calf)

    DI: 00817980021266 · Model: Model Lumenair · VASOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hose, Single, (Models MC2, TS3, TS4 and Lumenair for Lower Thigh And Calf)
    Primary DI
    00817980021266
    Version / Model
    Model Lumenair
    Catalog Number
    V53-0087-0
    Company Name
    VASOMEDICAL, INC.
    Labeler DUNS
    197210248
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-29
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    47b258c9-6f33-4c4e-83cb-d80448e1bdb8

    Device Description

    Hose, Single, (Models MC2, TS3, TS4 and Lumenair for Lower Thigh And Calf)

    Device Characteristics

    Single Use
    No
    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
    DRN Device, counter-pulsating, external

    GMDN Terms

    Code Name
    61282 External counterpulsation system, stationary

    Identifiers

    Type ID
    Primary 00817980021266

    Customer Contacts

    Phone
    +1(516)508-5818
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K033617 000