BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AED QC LEVEL 2

    DI: B800UTAKSCAED2SD0 · Model: UTAK-SC AED 2 SD · UTAK LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AED QC LEVEL 2
    Primary DI
    B800UTAKSCAED2SD0
    Version / Model
    UTAK-SC AED 2 SD
    Catalog Number
    UTAK-SC AED 2 SD
    Company Name
    UTAK LABORATORIES, INC.
    Labeler DUNS
    092519016
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-14
    Public Version
    1
    Public Version Date
    2023-06-22
    Public Version Status
    New
    Public Device Record Key
    d8d1217c-7a3e-4654-b1d1-959d96c62058

    Device Description

    AED QC LEVEL 2

    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
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Package B800UTAKSCAED2SD5
    Primary B800UTAKSCAED2SD0

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 3 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius