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510(k) Data Aggregation

    K Number
    K140516
    Device Name
    Terumo Pen Injector Needle 34
    Manufacturer
    KOFU FACTORY OF TERUMO CORP.
    Date Cleared
    2014-08-05

    (158 days)

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

    KOFU FACTORY OF TERUMO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.
    Device Description
    The Terumo® Pen Injector Needle 34 is comprised of a double-tapered stainless steel needle cannula that is pointed at both the cartridge interface end, to puncture the cartridge for drug delivery, and the patient interface end, for injection into the patient's body tissue. The patient interface end features a 3-bevel, asymmetrical needle edge. The cannula tapers from a 29G (0.33 mm) outer diameter at the cartridge interface end to a 34G (0.18 mm) outer diameter at the needle tip (patient interface end). It is normal-walled (min. 0.089 mm inner diameter) at the needle tip, and the internal diameter tapers like the outer diameter (wall thickness is uniform throughout the needle length). The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device). The needle insertion length (from the glue mount on the hub to the tip of the patient interface end) is 4 mm (5/32"). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case). The cartridge interface end is then covered with a sealing film. Just prior to use, the outer needle case is removed and retained for recapping once the injection is completed. The inner needle cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer needle case so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and sterilized by electron beam. It is a manually operated, disposable device intended for single use only.
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    K Number
    K141138
    Device Name
    SURFLASH SAFETY I.V. CATHETER
    Manufacturer
    KOFU FACTORY OF TERUMO CORP.
    Date Cleared
    2014-05-30

    (28 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOFU FACTORY OF TERUMO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids in the prevention of needle stick injuries. These cathers may patient population with consideration given to adequacy of vasular anatony and appropriateness for the solution being infused and duration of therapy. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.
    Device Description
    The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder). The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The grooved cannula, which allows the clinician to visualize flashback detection through the groove, indicates that there is confirmation of vessel entry. The whole length of the cannula, including the sharp end of the cannula, is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries.
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    K Number
    K123267
    Device Name
    SURFFLASH(R) PLUS SAFETY I.V. CATHETER
    Manufacturer
    KOFU FACTORY OF TERUMO CORP.
    Date Cleared
    2012-11-02

    (14 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOFU FACTORY OF TERUMO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURFLASH® Plus Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.
    Device Description
    The SURFLASH® Plus Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. The devices consist of catheter assembly (catheter, caulking pin and catheter hub containing valve, seal component and plug), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The SURFLASH® Plus Safety I.V. Catheter has a valve and a seal component inside the catheter hub to minimize the possibility of blood leakage at catheter hub after needle removal. The catheter hub is also provided with a plug inside which penetrates the valve to create a fluid path when a connector is inserted in the catheter hub. The fluid path is permanently opened once a secure luer connection is made. The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. Whole length cannula including the sharp end of the inner needle is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. The grooved cannula which allows the clinician to visualize flashback detection through the groove indicating that there is confirmation of vessel entry is the same as the TERUMO® Surshield® PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH® I.V. Catheter (K991406). The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The catheter that is advanced into the vessel is made of polyurethane which is the same as the TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH® I.V. Catheter (K991406).
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    K Number
    K052561
    Device Name
    TERUMO MICRO TAPERED PEN NEEDLE
    Manufacturer
    KOFU FACTORY OF TERUMO CORP.
    Date Cleared
    2005-11-23

    (65 days)

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

    KOFU FACTORY OF TERUMO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.
    Device Description
    The Terumo® Micro tapered pen needle is comprised of a stainless steel needle pointed at both ends with a 28gauge outer diameter at the vial end and tapers to a 33gauge outer diameter at the needle tip i.e. patient end. The tapered length is 3.5mm from the tip. The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device). It is designed to fit type A universal insulin pen injectors. The exposed patient-end needle length is 3/16" (5mm). The needle tip is covered by a colored plastic protective cap which is covered by a clear outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is completed. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and sterilized. It is a disposable device intended for single use only.
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