BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Level 1

    DI: 40695085401002 · Model: L-10 · ICU MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Level 1
    Primary DI
    40695085401002
    Version / Model
    L-10
    Company Name
    ICU MEDICAL, INC.
    Labeler DUNS
    118380146
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-14
    Public Version
    5
    Public Version Date
    2025-04-16
    Public Version Status
    Update
    Public Device Record Key
    3fed5684-38a8-4738-a2c8-437bc5ea1dbe

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGZ Warmer, thermal, infusion fluid

    GMDN Terms

    Code Name
    35072 Intravenous line filter

    Identifiers

    Type ID
    Package 30695085401005
    Package 20695085401008
    Package 10695085401001
    Primary 40695085401002

    Premarket Submissions

    Submission Number Supplement Number
    K911383 000