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510(k) Data Aggregation

    K Number
    K063151
    Device Name
    HUMAPEN LUXURA HD
    Manufacturer
    ELI LILLY AND CO.
    Date Cleared
    2007-01-09

    (85 days)

    Product Code
    NSC
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELI LILLY AND CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HumaPen Luxura HD is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 30 units in one-half (1/2) unit increments.
    Device Description
    HumaPen Luxura HD is a reusable mechanical pen-injector designed for the selfinjection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).
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    K Number
    K982842
    Device Name
    HUMAPEN AND HUMAPEN ERGO
    Manufacturer
    ELI LILLY AND CO.
    Date Cleared
    1998-09-25

    (44 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELI LILLY AND CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The peninjector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.
    Device Description
    HumaPen and HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen-injector uses 3.0 mL cartridges of insulin (Humalog® (human insulin[rDNA origin]) or Humulin® (insulin lispro injection [rDNA origin]) and a single use, detachable and disposable pen needle (supplied separately). The peninjector allows the user to dial the desired dose one unit at a time up to 60 units.
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