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510(k) Data Aggregation

    K Number
    K243273
    Device Name
    CeQur Simplicity™ On-Demand Insulin Delivery System
    Manufacturer
    CeQur SA
    Date Cleared
    2024-11-13

    (28 days)

    Product Code
    OPP
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    OPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
    Device Description
    The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The CeQur Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
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    K Number
    K233447
    Device Name
    CeQur Simplicity™ On-Demand Insulin Delivery System
    Manufacturer
    CeQur SA
    Date Cleared
    2024-01-18

    (91 days)

    Product Code
    OPP
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    OPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
    Device Description
    The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
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    K Number
    K163357
    Device Name
    OneTouch Via On-Demand Insulin Delivery System
    Manufacturer
    LifeScan Europe, a division of Cilag GmbH
    Date Cleared
    2017-06-07

    (189 days)

    Product Code
    OPP, LZG
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    OPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
    Device Description
    The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
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    K Number
    K111924
    Device Name
    FINESSE PERSONAL INSULIN DELIVERY PATCH
    Manufacturer
    CALIBRA MEDICAL, INC.
    Date Cleared
    2012-04-10

    (279 days)

    Product Code
    OPP, LZG
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    OPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus. The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
    Device Description
    The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive. The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery. The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.
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    K Number
    K100947
    Device Name
    FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
    Manufacturer
    CALIBRA MEDICAL, INC.
    Date Cleared
    2010-06-28

    (83 days)

    Product Code
    OPP
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    OPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
    Device Description
    The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and a drug delivery device filler. The device is adhered to the skin with a biocompatible adhesive. The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component. The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
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    K Number
    K093065
    Device Name
    FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
    Manufacturer
    CALIBRA MEDICAL, INC.
    Date Cleared
    2010-01-20

    (112 days)

    Product Code
    OPP, LZG
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    OPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
    Device Description
    The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and drug delivery device filler. The device is adhered to the skin for up to 48 hours with a biocompatible adhesive. The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component. The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
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