BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACETAMINOPHEN PLUS HIGH

    DI: B80010095200010 · Model: ACETA+ HIGH V2 S F BD · UTAK LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    7
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACETAMINOPHEN PLUS HIGH
    Primary DI
    B80010095200010
    Version / Model
    ACETA+ HIGH V2 S F BD
    Company Name
    UTAK LABORATORIES, INC.
    Labeler DUNS
    092519016
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-27
    Public Version
    1
    Public Version Date
    2022-05-05
    Public Version Status
    New
    Public Device Record Key
    09bcc1ec-14a2-44d3-84e0-c71389d39b69

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LAS Drug Specific Control Materials

    GMDN Terms

    Code Name
    55235 Multiple-therapy therapeutic drug monitoring IVD, control

    Identifiers

    Type ID
    Primary B80010095200010
    Package B80010095200011
    Package B80010095200012
    Package B80010095200013
    Package B80010095200016
    Package B80010095200017
    Package B80010095200018

    Customer Contacts

    Phone
    1-888-882-5522
    Email
    [email protected]