BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CLEARLINK/BURETROL

    DI: 00085412565705 · Model: 2R8864 · BAXTER HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CLEARLINK/BURETROL
    Primary DI
    00085412565705
    Version / Model
    2R8864
    Catalog Number
    2R8864
    Company Name
    BAXTER HEALTHCARE CORPORATION
    Labeler DUNS
    005083209
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-30
    Public Version
    3
    Public Version Date
    2023-08-15
    Public Version Status
    Update
    Public Device Record Key
    c32b2751-444b-4fe8-a326-957846f6bb97

    Device Description

    Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    FPA Set, administration, intravascular

    GMDN Terms

    Code Name
    35833 Electric infusion pump administration set, single-use

    Identifiers

    Type ID
    Package 50085412565700
    Primary 00085412565705

    Customer Contacts

    Phone
    +1(800)933-0303
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123874 000