BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Spacelabs Healthcare

    DI: 10841522103360 · Model: CDIRECT · SPACELABS HEALTHCARE (WASHINGTON), INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Spacelabs Healthcare
    Primary DI
    10841522103360
    Version / Model
    CDIRECT
    Catalog Number
    41-0053EU
    Company Name
    SPACELABS HEALTHCARE (WASHINGTON), INC
    Labeler DUNS
    145581588
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-07
    Public Version
    3
    Public Version Date
    2021-03-10
    Public Version Status
    Update
    Public Device Record Key
    d6e9f444-3259-49a3-8843-2951e1bc786d
    Distribution End Date
    2019-01-31

    Device Description

    RESTING ECG HOOK UP SET,NON DISPOSABLE,EU

    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
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DPS Electrocardiograph

    GMDN Terms

    Code Name
    16231 Electrocardiograph, professional, multichannel

    Identifiers

    Type ID
    Primary 10841522103360