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510(k) Data Aggregation

    K Number
    K242434
    Device Name
    Insulin Syringes
    Manufacturer
    CHIRANA T. Injecta
    Date Cleared
    2024-12-24

    (130 days)

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

    CHIRANA T. Injecta

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
    Device Description
    The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.
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    K Number
    K220614
    Device Name
    MEDOJECT fine Pen Needles
    Manufacturer
    Chirana T. Injecta
    Date Cleared
    2022-06-15

    (104 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chirana T. Injecta

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K201044
    Device Name
    CHIRANA Insulin Syringes
    Manufacturer
    CHIRANA T. Injecta
    Date Cleared
    2022-01-18

    (637 days)

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

    CHIRANA T. Injecta

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
    Device Description
    The CHIRANA® Insulin Syringes are a 0.3mL, 0.5mL, or 1.0mL syringes designed for subcutaneous injection of a desired dose of insulin. The CHIRANA® Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, and 12.7mm). The CHIRANA® Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.
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    K Number
    K201009
    Device Name
    CHIRAVAC Blood Collection Needles
    Manufacturer
    CHIRANA T. Injecta
    Date Cleared
    2021-07-21

    (460 days)

    Product Code
    JKA, FMI
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHIRANA T. Injecta

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
    Device Description
    The CHIRAVAC™ Blood Collection Needles consists of a double-ended hollow stainless steel thin-walled cannula, a threaded polypropylene hub, a sleeve that interrupts blood flow between filling multiple tubes, and polypropylene caps. The device is single use and supplied sterile (ethylene oxide sterilized). The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have no contact with patient blood, tissue, or skin. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to be used to collect blood from the vein puncture.
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