BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fetal Monitor Remote Display

    DI: B321598221010020 · Model: ETCX X98-1 (CM9) · CLINICOMP INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fetal Monitor Remote Display
    Primary DI
    B321598221010020
    Version / Model
    ETCX X98-1 (CM9)
    Company Name
    CLINICOMP INTERNATIONAL, INC.
    Labeler DUNS
    113412019
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    4
    Public Version Date
    2020-05-19
    Public Version Status
    Update
    Public Device Record Key
    7fd43b0b-386e-4d97-8eac-8df4ab5f9e2b

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    HGM System, Monitoring, Perinatal

    GMDN Terms

    Code Name
    38470 Centralized patient monitor

    Identifiers

    Type ID
    Primary B321598221010020

    Customer Contacts

    Phone
    8003508202
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K931133 000

    Device Sizes

    Type Value Unit Text
    Width 12 Inch
    Height 2 Inch
    Length 12 Inch
    Weight 5.5 Pound

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 35 Degrees Celsius