BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AIMSTRIP HEMOGLOBIN METER

    DI: 00695684781019 · Model: 78101 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AIMSTRIP HEMOGLOBIN METER
    Primary DI
    00695684781019
    Version / Model
    78101
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    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
    88825c63-f0f2-4cd7-9aa9-cd1f7311c4e8

    Device Description

    For the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA or sodium heparin. The testing system is designed for point-of-care use in primary care settings.

    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
    55873 Total haemoglobin (totHb) IVD, kit, enzyme spectrophotometry

    Identifiers

    Type ID
    Primary 00695684781019