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510(k) Data Aggregation

    K Number
    K071613
    Device Name
    AMIGO INSULIN PUMP
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Date Cleared
    2007-12-14

    (184 days)

    Product Code
    LZG, REG
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO DIABETES SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin.
    Device Description
    The proposed Amigo® Insulin Pump is a small, lightweight, battery-operated programmable insulin infusion pump. The pump houses a replaceable single-use insulin syringe containing up to 300 units (3mL) of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set. Various hardware and software systems monitor the pump's operation and provide a method of control and monitor function to keep the pump within safe parameters. A hierarchy of alarms based on IEC 60601-1-8 criteria and priorities notifies the user to possible error conditions. Notifications are via visual, audible, and vibration means through the use of the LCD backlight, the audio speaker, and a vibrator motor, respectively. If the alarm priority warrants, the system is put into a safe state with infusion stopped. Power is provided by a user-replaceable primary battery (CR2), allowing for a minimum of 22 days of typical usage. An internal, rechargeable backup battery is used for primary battery end-of-life alarms and for operating redundancy. Provision is made for an infrared communications port, which is accessible only to Nipro for manufacturing use.
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    K Number
    K050312
    Device Name
    AMIGO INSULIN PUMP
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Date Cleared
    2005-05-09

    (90 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO DIABETES SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amigo Insulin Pump is intended for the subcutaneous infusion of insulin.
    Device Description
    The Amigo Insulin Pump is a small, lightweight, battery-operated programmable Insulin infusion pump. The pump houses a replaceable Nipro GlucoPro™ single-use insulin syringe containing up to 300 units of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set.
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    K Number
    K014114
    Device Name
    GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Date Cleared
    2002-06-26

    (194 days)

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

    NIPRO DIABETES SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glucopro syringe is intended for use in the subcutancous infusion of insuline to tast "Inte GlucoPro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syringe. The insulin is infused from an external infusion pump.
    Device Description
    The Glucopro Syringe is a medication reservoir placed within an infusion pump and attached to an infusion set for infusion of medicine solutions, such as insulin. The materials used for the components include: stainless steel; polypropylene; and, silicone. All of these materials are typically used in medical devices.
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    K Number
    K013309
    Device Name
    GLUCOPRO EVO INFUSION PUMP
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Date Cleared
    2002-06-24

    (263 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO DIABETES SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.
    Device Description
    The Gluc. Pro Infusion Pump is intended for use with the disposable compatible infusion sets and the GlucoPro syringe for subcutaneous delivery of insulin. The catheter or needle of the compatible infusion set is inserted into the subcutaneous tissue of the user and is connected to the syringe that it the drug reservoir. The syringe is installed in the infusion pump and attached by means of screw threads. The medicine solution is delivered and infused info the user continuously. The user sets continuous basal infusion rate and selects bolus delivery. The infusion punip contains many safety teatures including alarms to indicate infusion error or system malfunction. The pump is 91 mm wide, 52 mm in leight, and 21 mm in depth. It weighs 80 grams. The power is supplied by a Duracell CR-2 (3V) ba tery (or equivalent) that should last 30 - 60 days.
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    K Number
    K011120
    Device Name
    GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Date Cleared
    2001-05-08

    (26 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO DIABETES SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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