BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Spacelabs Healthcare

    DI: 10841522106675 · Model: 90207 · 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
    10841522106675
    Version / Model
    90207
    Catalog Number
    N/A
    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
    2016-11-03
    Public Version
    4
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    7dc09d0f-c92a-46f5-b7aa-6a052c9bbb46
    Distribution End Date
    2016-12-31

    Device Description

    Blood Pressure Long-Term Ambulatory Recorder

    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
    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
    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
    DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

    GMDN Terms

    Code Name
    36888 Blood pressure ambulatory recorder

    Identifiers

    Type ID
    Primary 10841522106675

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 0 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    0 – 0 Percent (%) Relative Humidity