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510(k) Data Aggregation

    K Number
    K091042
    Device Name
    CRONO S-PID 50
    Manufacturer
    CANE S.R.L.
    Date Cleared
    2009-05-12

    (29 days)

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

    CANE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the Crono S-PID 50 has been designed for use in subcutaneous infusion of prescribed liquid medicines.
    Device Description
    Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono, a perfect combination of high technology and innovative design. Crono S-PID 50 is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion. Crono S-PID 50 combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time during the day without interrupting daily life or leisure activities. Crono S-PID 50 pump uses 50 ml dedicated syringes. Crono S-PID 50 has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration. Crono S-PID 50 administers 20 ul per impulse. In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. Crono S-PID 50 is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
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    K Number
    K052218
    Device Name
    CRONO FIVE AND CRONO PCA 50
    Manufacturer
    CANE S.R.L.
    Date Cleared
    2005-11-23

    (100 days)

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

    CANE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.
    Device Description
    Crono Five is a new, innovative ambulatory infusion pump that is very appreciated by health care professionals and patients due to its small size and technical features. Crono Five is especially suited for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intra-venous, epidural and intrathecal infusions allowing 4 different administration modalities: 1. Continuous 2. Bolus dose upon request (PCA) 3. Clinician bolus (managed by clinician) 4. Combined (continuous + bolus upon request + clinician bolus). Crono Five pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol. The liquid crystal display (LCD) can show relevant information to caregivers and patients like programmed values, amount of drug delivered, remaining delivery time etc. Crono PCA 50 is essentially the same as the Crono Five, but has a 50 ml infusion capacity.
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    K Number
    K052217
    Device Name
    CRONO SUPER PID
    Manufacturer
    CANE S.R.L.
    Date Cleared
    2005-09-13

    (29 days)

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

    CANE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the Crono Super PID has been designed for use in subcutaneous infusion of prescribed liquid medicines.
    Device Description
    Crono Super PID is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion. Crono Super PID combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time daring the day without interrupting daily life or leisure activities. Crono Super PID pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono Super PID has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration. Crono Super PID administers 22 µl per impulse. In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. Crono Super PID is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
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    K Number
    K052219
    Device Name
    CRONO GO.
    Manufacturer
    CANE S.R.L.
    Date Cleared
    2005-09-13

    (29 days)

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

    CANE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the Crono go has been designed for use in subcutaneous infusion of prescribed liquid medicines.
    Device Description
    Crono go is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion. Crono go combines high technology with innovative design. Thanks to the small size of the pump Crono go can administer the drug any time during the day without interrupting daily life or leisure activities. Crono go pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono go has a particular mechanism which pushes directly on the rubber syringe piston, which guarantees a significant thrust force and high accuracy of administration. Additional bolus doses can be easily administered by pressing a dedicated button, and the administered bolus dose is shown on the display screen. In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. Crono go is fitted with a liquid crystal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
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    K Number
    K042085
    Device Name
    CRONO F
    Manufacturer
    CANE S.R.L.
    Date Cleared
    2004-09-17

    (45 days)

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

    CANE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable Crono infusion devices have been designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
    Device Description
    Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono F, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono F allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Patients who have been following a liquid medicine therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono F has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono F makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 µl per impulse, using a 10/20 ml syringe). Crono F is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
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    K Number
    K041414
    Device Name
    CRONO AND CRONO, MODEL 30
    Manufacturer
    CANE S.R.L.
    Date Cleared
    2004-07-08

    (42 days)

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

    CANE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crono and Crono 30 ambulatory infusion pump devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.
    Device Description
    Canc s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono, a perfect combination of high technology and innovative design. The infusion pumps witch use normal commercial syringes are inevitably cumbersome and thus difficult to mee in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Points who have been following a liquid medicine therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 timss ligher with respect to conventional pumps. In case of catheter occlusion, an innovative influsion control system makes it possible to proceed with the infusion automatically and, after the occlusion is climinated, to complete it. For a better absorption of the drug, Crono makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ul per impulse, using a 10/20 ml syringe). Crono is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status. The Crono 30 is essenially the same as the Crono, but has a 30 ml infusion capacity. It infuses at a rate of 3 ml per impulse.
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