BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AgaMatrix Lancing Device

    DI: 00385541062206 · Model: 8300-10622 · AGAMATRIX, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AgaMatrix Lancing Device
    Primary DI
    00385541062206
    Version / Model
    8300-10622
    Company Name
    AGAMATRIX, INC.
    Labeler DUNS
    156756129
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-18
    Public Version
    1
    Public Version Date
    2023-09-26
    Public Version Status
    New
    Public Device Record Key
    a4a6e712-0fad-4b88-9c11-f75a25c1647a

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    QRL Multiple Use Blood Lancet For Single Patient Use Only
    QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

    GMDN Terms

    Code Name
    37243 Manual blood lancing device, reusable

    Identifiers

    Type ID
    Primary 00385541062206

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K230310 000