BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AgaMatrix

    DI: 10385542661016 · Model: 8000-02661 · AGAMATRIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AgaMatrix
    Primary DI
    10385542661016
    Version / Model
    8000-02661
    Catalog Number
    8000-10877
    Company Name
    AGAMATRIX, INC.
    Labeler DUNS
    156756129
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-04
    Public Version
    5
    Public Version Date
    2021-12-30
    Public Version Status
    Update
    Public Device Record Key
    54eb7d89-f771-459b-974d-dc1da8fa14ca

    Device Description

    Blood Glucose Meter, AgaMatrix, Presto, mg/dL

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 10385542661016

    Customer Contacts

    Phone
    1-866-906-4197
    Email
    [email protected]