BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LITHIUM 15 MMOL/L

    DI: B800LIT15SFBD0 · Model: LIT 15 S F BD · UTAK LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LITHIUM 15 MMOL/L
    Primary DI
    B800LIT15SFBD0
    Version / Model
    LIT 15 S F BD
    Catalog Number
    LIT 15 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
    2023-10-26
    Public Version
    1
    Public Version Date
    2023-11-03
    Public Version Status
    New
    Public Device Record Key
    ad5b36a1-8693-4842-bc34-45d94f02d8c1

    Device Description

    LITHIUM 15 MMOL/L

    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
    No
    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
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Package B800LIT15SFBD5
    Primary B800LIT15SFBD0

    Customer Contacts

    Phone
    18888825522
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 10 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -10 Degrees Celsius