BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Microphone Pads, Bag of 50

    DI: 10840935107781 · Model: 98-0002-50 · SUNTECH MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Microphone Pads, Bag of 50
    Primary DI
    10840935107781
    Version / Model
    98-0002-50
    Company Name
    SUNTECH MEDICAL, INC.
    Labeler DUNS
    148191133
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2018-01-12
    Public Version
    4
    Public Version Date
    2019-11-08
    Public Version Status
    Update
    Public Device Record Key
    6532c1b7-d351-4428-b7eb-b699f6818fd9

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    16173 Automatic-inflation electronic sphygmomanometer, non-portable

    Identifiers

    Type ID
    Primary 10840935107781
    Unit of Use 00840935107784

    Customer Contacts

    Phone
    1-919-654-2300
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K122401 000