BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cooling pump

    DI: 08809295147054 · Model: RFP-300 · RF Medical Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Cooling pump
    Primary DI
    08809295147054
    Version / Model
    RFP-300
    Company Name
    RF Medical Co.,Ltd.
    Labeler DUNS
    690514869
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-31
    Public Version
    1
    Public Version Date
    2019-08-08
    Public Version Status
    New
    Public Device Record Key
    477e2b59-dc11-486d-a86c-ee4e9663d3f9

    Device Description

    The Cooling pump RFP-300 is used to cooling of the electrodes by circulating saline solution.

    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    37147 Cooling utility supply system

    Identifiers

    Type ID
    Primary 08809295147054

    Customer Contacts

    Phone
    +82221084200
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180999 000

    Device Sizes

    Type Value Unit Text
    Height 210 Millimeter
    Depth 274 Millimeter
    Width 200 Millimeter
    Weight 3.75 Kilogram

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius