BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EXACTAMIX

    DI: 05413765477584 · Model: H9382400-DY · BAXTER HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EXACTAMIX
    Primary DI
    05413765477584
    Version / Model
    H9382400-DY
    Catalog Number
    H9382400-DY
    Company Name
    BAXTER HEALTHCARE CORPORATION
    Labeler DUNS
    005083209
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2023-07-20
    Public Version Status
    Update
    Public Device Record Key
    be5df70f-56bf-4fca-81a4-4f8c47938034

    Device Description

    EXACTAMIX Compounder, EM2400 Display

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NEP SYSTEM/DEVICE, PHARMACY COMPOUNDING

    GMDN Terms

    Code Name
    17459 Intravenous solution compounder

    Identifiers

    Type ID
    Primary 05413765477584

    Customer Contacts

    Phone
    +1(800)678-2292
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 64 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 80 Percent (%) Relative Humidity
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 80 Percent (%) Relative Humidity