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510(k) Data Aggregation

    K Number
    K080954
    Device Name
    T34L SYRINGE DRIVER
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2008-05-16

    (43 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T34L SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.
    Device Description
    The T34L SYRINGE DRIVER SYSTEM includes: Syringe Pump External Charger Extension Tube Bolus cable (optional)
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    K Number
    K070235
    Device Name
    BODYGUARD PAIN MANAGER INFUSION SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2007-05-18

    (113 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuard infusion Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes, of administration, including intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.
    Device Description
    The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
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    K Number
    K070718
    Device Name
    MODIFICATION TO: BODYGUARD INFUSION SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2007-04-13

    (30 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.
    Device Description
    The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)
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    K Number
    K061325
    Device Name
    BODYGAURD PAIN MANAGER INFUSION SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2006-08-24

    (105 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)
    Device Description
    Not Found
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    K Number
    K060479
    Device Name
    MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2006-05-12

    (78 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuard infusion Pump system is designed for infusion and monitoring. The pump is intended for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). Monitoring accessory currently includes Pulse Oximeter, used for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy. The system is indicated for use with adult, pediatric and neonatal patients in hospital and home care environments.
    Device Description
    The BodyGuard Infusion system includes: Infusion Pump (one/dual channel models) Docking Station Bolus cable (optional) Drop sensor (optional) Pulse Oximeter (optional)
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    K Number
    K050800
    Device Name
    NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2005-11-23

    (238 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T34 SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.
    Device Description
    The T34 SYRINGE DRIVER SYSTEM includes: Syringe Pump Extension Tube Bolus cable (optional)
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    K Number
    K042696
    Device Name
    BODYGUARD INFUSION PUMP SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2005-03-11

    (162 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of administration (e.g. intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, regional, or surgical wound site). The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.
    Device Description
    The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
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    K Number
    K040957
    Device Name
    NOA III ENTERAL NUTRITION PUMP
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2004-05-21

    (38 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates. The pump is designed to be used in hospital and home care environments. The pump can be used in stationary and ambulatory ways.
    Device Description
    The NOA III Enteral Nutrition System includes: Infusion Pump, Battery Charger.
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    K Number
    K031749
    Device Name
    BODYGUARD INFUSION SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2003-08-21

    (77 days)

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

    CAESAREA MEDICAL ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.
    Device Description
    The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet female luer) PCA cable (optional) Charging cable (optional)
    Ask a Question

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