BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SENSUS

    DI: 00851221006339 · Model: SE-SY4 · NEUROMETRIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SENSUS
    Primary DI
    00851221006339
    Version / Model
    SE-SY4
    Company Name
    NEUROMETRIX, INC.
    Labeler DUNS
    957536014
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    4
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    1c15a88f-0462-4409-a854-456b25bf1e9f

    Device Description

    SENSUS System, 4-lead configuration 2 SE-001, SE-C01, charger, cable

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 00851221006339

    Customer Contacts

    Phone
    781-314-2781
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K130919 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 50 Degrees Celsius