BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COMFORT TOUCH

    DI: 00850024759404 · Model: Blood Cuff · Slv Pharmaceuticals LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COMFORT TOUCH
    Primary DI
    00850024759404
    Version / Model
    Blood Cuff
    Company Name
    Slv Pharmaceuticals LLC
    Labeler DUNS
    081225162
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-10
    Public Version
    1
    Public Version Date
    2021-05-18
    Public Version Status
    New
    Public Device Record Key
    6fd2fea6-a3bf-4551-ae02-c9da98283ed7

    Device Description

    COMFORT TOUCH BLOOD PRESSURE CUFF - LARGE

    Device Characteristics

    Single Use
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    17105 Walking aid handgrip

    Identifiers

    Type ID
    Primary 00850024759404

    Premarket Submissions

    Submission Number Supplement Number
    K160019 000