BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SONICAID

    DI: 05051968029836 · Model: ACC-OBS-009L · HUNTLEIGH HEALTHCARE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SONICAID
    Primary DI
    05051968029836
    Version / Model
    ACC-OBS-009L
    Catalog Number
    ACC-OBS-009L
    Company Name
    HUNTLEIGH HEALTHCARE LIMITED
    Labeler DUNS
    217207083
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    5
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    d16d8343-852c-4f6a-8630-3e1c07a7d988

    Device Description

    SONCD FM800 ENCOR EXT TOCO TDR-3M

    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
    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
    37258 Tocodynamometer probe

    Identifiers

    Type ID
    Primary 05051968029836

    Customer Contacts

    Phone
    +4402920485885
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K090285 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    10 – 35 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 75 Percent (%) Relative Humidity
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    680 – 1060 millibar
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    680 – 1060 millibar