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510(k) Data Aggregation

    K Number
    K100704
    Device Name
    ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2010-05-14

    (63 days)

    Product Code
    FRN, FPA, KZH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets.
    Device Description
    The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus. The ACCU-CHEK® LinkAssist Plus is an insertion aid for automatic application of ACCU-CHEK® infusion sets equipped with a compatible adapter. The ACCU-CHEK® LinkAssist device is non-invasive, non-sterile and intended for multiple uses by the same patient.
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    K Number
    K070189
    Device Name
    ACCU-CHEK ULTRAFLEX INFUSION SET
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2007-02-21

    (30 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
    Device Description
    The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
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    K Number
    K063146
    Device Name
    ACCU-CHEK LINKASSIST
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2006-11-27

    (42 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.
    Device Description
    The Accu-Chek LinkAssist is an insertion aid for automatic application of the Accu-Chek infusion sets with compatible adapter. It permits introduction of the infusion set cannula into the subcutaneous fatty tissue. The Accu-Chek LinkAssist is made of plastic and stainless steel components and has spring loaded mechanisms. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The connection between the Accu-Chek LinkAssist device and the infusion set is established by means of a compatible sterile adapter.
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    K Number
    K060876
    Device Name
    ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2006-06-15

    (76 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
    Device Description
    The ACCU-CHEK Spirit Insulin Infusion Pump is an ambulatory, battery operated insulin pump designed for continuous delivery of insulin. The design allows for delivery of 0.0 to 25.0 units of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per meal or meal bolus. The pump is made of impact resistant plastic. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. The ACCU-CHEK Spirit Insulin Infusion Pump is equipped with an IR-Interface in order to enable data transmission between the pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
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    K Number
    K042887
    Device Name
    ACCU-CHEK SPIRIT
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2005-03-18

    (150 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
    Device Description
    The ACCU-CHEK Spirit Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows the delivery of 0.1 to 25.0 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal or meal bolus.
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    K Number
    K043000
    Device Name
    MODIFICATION TO D-TRONPLUS
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2004-12-01

    (30 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.
    Device Description
    The D-TRONplus Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows settings of 0.0 to 25.0 units in 0.1 unit increments of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per bolus in 0.1, 0.2, 0.5, or 1.0 unit increments.
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    K Number
    K033892
    Device Name
    ULTRAFLEX INFUSION SET
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2004-03-09

    (84 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
    Device Description
    The Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
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    K Number
    K023471
    Device Name
    DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2002-10-29

    (14 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disetronic H-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self-glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.
    Device Description
    The Disetronic H-TRONplus Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and has easy to feel buttons to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, piston rod, cartridge and adapter. The H-TRONplus Insulin Infusion Pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a DC motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or his or her health care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the three buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump.
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    K Number
    K022831
    Device Name
    MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2002-09-11

    (16 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.
    Device Description
    The Disetronic D-TRONplus Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter, cartridge and the optional PC software that allows convenient programming of the pump or monitoring of the therapy. Furthermore the pump's data memory can be read out and displayed by using third party diabetes management software. The D-TRONplus Insulin Infusion Pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump. The D-TRONblus pump is equipped with an infrared interface that allows data transmission between the pump and a personal computer. Disetronic provides the DiaLog PC software as an accessory to the D-TRONplus pump that facilitates the programming and monitoring of the device.
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    K Number
    K021725
    Device Name
    DISETRONIC D-TRON INSULIN INFUSION PUMP
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Date Cleared
    2002-08-02

    (70 days)

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

    DISETRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications For Use: as prescribed by a physician. as proombod by a prifortialin dependent diabetes Mellitus who do not have optimum it is indication partional insulin injection therapy. Patients for insulin pump blood gradose of the or beform self glucose monitoring on a frequent and regular therapy made be highty the a proper diet and exercise regiment. Patients must be capable of busic, as well and anot over also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.
    Device Description
    The Disetronic D-TRON Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter and custom reservoir kit. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the basal infusion each hour for twenty four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump. Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U. The D-TRON Insulin Infusion pump is equipped with an IR-Interface in order to enable data transmissions between the pump and a personal computer. The DiaLog PC-Software facilitates the monitoring and programming of the pump settings. Current pump settings can be displayed on the computer monitor, adjustments can be made and re-stored into the pump.
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