BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ICU Medical

    DI: 00887709072121 · Model: AM6102 · ICU MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ICU Medical
    Primary DI
    00887709072121
    Version / Model
    AM6102
    Company Name
    ICU MEDICAL, INC.
    Labeler DUNS
    118380146
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-16
    Public Version
    6
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    33a4eba8-d71f-4f71-b23c-9f074580f52d

    Device Description

    129" 10 Drop Primary Set w/4 Pre-Slit Ports, 6-Port NanoClave® Manifold, Check Valve, 4-Way Stopcock, Rotating Luer, 1 Ext

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    FMG Stopcock, i.V. Set

    GMDN Terms

    Code Name
    58977 Basic intravenous administration set, noninvasive

    Identifiers

    Type ID
    Package 10887709072128
    Primary 00887709072121

    Premarket Submissions

    Submission Number Supplement Number
    K964435 000