BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ClampEase P-Series Disc

    DI: 10815614021047 · Model: P-700 · SEMLER TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ClampEase P-Series Disc
    Primary DI
    10815614021047
    Version / Model
    P-700
    Catalog Number
    150-2031-70a
    Company Name
    SEMLER TECHNOLOGIES, INC.
    Labeler DUNS
    042075700
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-01
    Public Version
    2
    Public Version Date
    2023-07-03
    Public Version Status
    Update
    Public Device Record Key
    f66cac07-3155-46b4-9b06-1621f927f6a7

    Device Description

    The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with a BALL attach.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXC Clamp, Vascular

    GMDN Terms

    Code Name
    47927 Femoral artery compression system, manual, single-use

    Identifiers

    Type ID
    Package 20815614021044
    Primary 10815614021047
    Package 30815614021041

    Premarket Submissions

    Submission Number Supplement Number
    K863427 000