BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eurotrol AlbuTrol

    DI: 08718734960645 · Model: AlbuTrol Level 2 · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eurotrol AlbuTrol
    Primary DI
    08718734960645
    Version / Model
    AlbuTrol Level 2
    Catalog Number
    189.002.002
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-08
    Public Version
    1
    Public Version Date
    2020-10-16
    Public Version Status
    New
    Public Device Record Key
    697bb490-77fd-4985-8bc8-34cb1f0b7647

    Device Description

    Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin.

    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
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    37721 Albumin IVD, control

    Identifiers

    Type ID
    Package 08718734960638
    Primary 08718734960645

    Premarket Submissions

    Submission Number Supplement Number
    K060215 000