BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec

    DI: 00646311490163 · Model: IV-018N · SB-KAWASUMI LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec
    Primary DI
    00646311490163
    Version / Model
    IV-018N
    Company Name
    SB-KAWASUMI LABORATORIES, INC.
    Labeler DUNS
    690625850
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    7
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    a15bf9a2-b7be-4f67-a123-577785c8ff7d
    Distribution End Date
    2019-12-31

    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    58977 Basic intravenous administration set, noninvasive

    Identifiers

    Type ID
    Primary 00646311490163