BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AIMSTRIP HEMOGLOBIN TEST CARTRIDGES

    DI: 00695684781507 · Model: 78150 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    AIMSTRIP HEMOGLOBIN TEST CARTRIDGES
    Primary DI
    00695684781507
    Version / Model
    78150
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-05-11
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    aea536ce-5896-4e8c-b053-4fb01fd9d188

    Device Description

    The AimStrip® Hemoglobin Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA or sodium heparin.

    Device Characteristics

    Single Use
    Yes
    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
    GKR System, Hemoglobin, Automated

    GMDN Terms

    Code Name
    57273 Haemoglobin detection IVD, reagent

    Identifiers

    Type ID
    Primary 00695684781507
    Unit of Use 00695684781501