BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    12-Ch ECG Holter Patient Cable w/10 Leads

    DI: 00817980020580 · Model: Model 1304 · VASOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    12-Ch ECG Holter Patient Cable w/10 Leads
    Primary DI
    00817980020580
    Version / Model
    Model 1304
    Catalog Number
    A10-0054
    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
    b4f9b5ac-0d1b-418a-ac8a-57284679634f

    Device Description

    12-Ch ECG Holter Patient Cable w/10 Leads

    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
    DSH RECORDER, MAGNETIC TAPE, MEDICAL

    GMDN Terms

    Code Name
    35562 Electrocardiographic lead set, reusable

    Identifiers

    Type ID
    Primary 00817980020580

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K111180 000