BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Codonics Safe Label System®(SLS) 550i Point of Care Station

    DI: 00814905020366 · Model: 550i PCS · CODONICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Codonics Safe Label System®(SLS) 550i Point of Care Station
    Primary DI
    00814905020366
    Version / Model
    550i PCS
    Company Name
    CODONICS INC.
    Labeler DUNS
    101533727
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-11
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    74356074-ca47-45e9-bf18-d2089f76b6c2

    Device Description

    Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items

    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
    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
    BSZ Gas-Machine, Anesthesia

    GMDN Terms

    Code Name
    18169 Parenteral-nutrition management software

    Identifiers

    Type ID
    Primary 00814905020366

    Customer Contacts

    Phone
    4402431334
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K101439 000