BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CompressAR XTS Stand

    DI: 10815614020286 · Model: 5000 · SEMLER TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CompressAR XTS Stand
    Primary DI
    10815614020286
    Version / Model
    5000
    Catalog Number
    150-0009-02
    Company Name
    SEMLER TECHNOLOGIES, INC.
    Labeler DUNS
    042075700
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-20
    Public Version
    4
    Public Version Date
    2023-02-03
    Public Version Status
    Update
    Public Device Record Key
    47ea8373-9e22-450e-b4b4-ad67a5da2291

    Device Description

    The CompressAR XTS Stand is used with CompressAR Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXC Clamp, Vascular

    GMDN Terms

    Code Name
    46367 Femoral artery compression system, manual, reusable

    Identifiers

    Type ID
    Primary 10815614020286