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510(k) Data Aggregation

    K Number
    K052221
    Device Name
    AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    2005-12-08

    (115 days)

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

    SORENSON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia. Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural. The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
    Device Description
    Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.
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    K Number
    K033325
    Device Name
    AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    2003-11-06

    (21 days)

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

    SORENSON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ambIT™ Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.
    Device Description
    Sorenson Medical's amblT™ Continuous Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for continuous fluid delivery to specified output requirements
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    K Number
    K033425
    Device Name
    AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    2003-11-06

    (10 days)

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

    SORENSON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.
    Device Description
    Sorenson Medical's amblT™ Intermittent Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for intermittent fluid delivery to specified output requirements.
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    K Number
    K002434
    Device Name
    PALM PUMP
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    2000-08-23

    (14 days)

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

    SORENSON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001287
    Device Name
    EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    2000-06-09

    (46 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SORENSON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991363
    Device Name
    30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    1999-05-13

    (23 days)

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

    SORENSON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All Pumps are for the infusion of fluids and medications into a body. The 30 Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.
    Device Description
    Not Found
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