BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HemoTrol Duo

    DI: 08718734961215 · Model: Normal · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HemoTrol Duo
    Primary DI
    08718734961215
    Version / Model
    Normal
    Catalog Number
    AN01624A02
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-20
    Public Version
    1
    Public Version Date
    2019-12-30
    Public Version Status
    New
    Public Device Record Key
    b3f7b57a-8c45-4df0-957b-60ec6c92b732

    Device Description

    HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GGM Control, Hemoglobin

    GMDN Terms

    Code Name
    55874 Total haemoglobin (totHb) IVD, control

    Identifiers

    Type ID
    Package 08718734961246
    Primary 08718734961215

    Premarket Submissions

    Submission Number Supplement Number
    K192842 000