BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Equivital LifeMonitor

    DI: 05060483830001 · Model: EQ-02-SEM-007 · HIDALGO LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Equivital LifeMonitor
    Primary DI
    05060483830001
    Version / Model
    EQ-02-SEM-007
    Company Name
    HIDALGO LIMITED
    Labeler DUNS
    896220522
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    18f889aa-e8f5-4317-b5ff-2166f24f31b3

    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 05060483830001

    Customer Contacts

    Phone
    +4401954233430
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K113054 000

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    0 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 55 Degrees Celsius