BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Boule EasyCleaner

    DI: 07350040791417 · Model: Boule EasyCleaner, 50ml · Boule Medical AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Boule EasyCleaner
    Primary DI
    07350040791417
    Version / Model
    Boule EasyCleaner, 50ml
    Catalog Number
    1504513
    Company Name
    Boule Medical AB
    Labeler DUNS
    354417933
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-04
    Public Version
    1
    Public Version Date
    2024-10-14
    Public Version Status
    New
    Public Device Record Key
    4e7ac831-eb2c-4608-bb4b-c17365e7d38d

    Device Description

    Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JCB Detergent

    GMDN Terms

    Code Name
    55855 Full blood count IVD, reagent

    Identifiers

    Type ID
    Primary 07350040791417

    Customer Contacts

    Phone
    1800-453-3328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius