BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Omron Pain Relief Pro

    DI: 00073796633141 · Model: PM3031CAN · Omron Healthcare, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Omron Pain Relief Pro
    Primary DI
    00073796633141
    Version / Model
    PM3031CAN
    Catalog Number
    PM3031CAN
    Company Name
    Omron Healthcare, Inc.
    Labeler DUNS
    054318779
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-17
    Public Version
    4
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    138ca0c8-7479-45f6-bcc1-94ad34e650ee

    Device Description

    Electrotherapy Pain Relief TENS Unit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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 00073796633141
    Package 10073796633148

    Customer Contacts

    Phone
    1-800-634-4350
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K110068 000