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510(k) Data Aggregation

    K Number
    K161811
    Device Name
    Medela Low Dose Enteral Syringe
    Manufacturer
    Medela, Inc.
    Date Cleared
    2017-02-15

    (229 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medela, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medela Low Dose Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.
    Device Description
    The Medela Low Dose Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is a low dose tip designed to allow for the delivery of fluid to a patient's feeding tube within +/-10%. The Medela Low Dose Enteral Syringe is offered in 1mL and 3mL sizes and intended to connect with devices equipped with ENFit connectors.
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    K Number
    K161725
    Device Name
    Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
    Manufacturer
    MEDELA, INC
    Date Cleared
    2016-10-28

    (128 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonata breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Sonata breast pump is intended for a single user.
    Device Description
    The Sonata™ breast pump and kit are used to express and collect mills from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. The system is not designed for mobile use. Pumping with the Sonata™ breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The Sonata™ breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.
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    K Number
    K031614
    Device Name
    MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
    Manufacturer
    MEDELA, INC.
    Date Cleared
    2003-06-06

    (14 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pump in Style® Advanced Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.
    Device Description
    The Medela® Pump in Style® Advanced Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. The Pump In Style® Advanced Breastpump employs a diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge, providing speed and directional control over the DC motor. The Pump In Style® Advanced Breastpump can be powered by external batteries or a wall plug transformer or by a 12 VDC vehicle lighter adapter. The control program resides in a microcontroller, inside the Pump In Style® Advanced Breastpump and provides the necessary a) time and b) vacuum parameters. By adjusting the knob, the microcontroller changes the vacuum and time parameters of the suction. The breast pump is capable of providing vacuum levels from 0 to 250mm Hg, with cycling rates up to 120 cycles per minute. The program residing on the microcontroller is designed to deliver two pumpina curves. All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.
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    K Number
    K020518
    Device Name
    MEDELA SYMPHONY BREAST PUMP, MODEL 024
    Manufacturer
    MEDELA, INC.
    Date Cleared
    2002-03-07

    (16 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
    Device Description
    The Symphony Powered Breast Pump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. A DC motor is employed to drive both diaphragm pumps, one for each breast. The diaphragm pumps create the negative pressure (suction), required to extract the breast milk. Because the motor is controlled by a programmable microcontroller, the mother can potentially select from a number of pumping (suction) programs. The pumping programs are stored on separate pumping cards, which are inserted into the Breast Pump, prior to operating the device. The card is similar in size to a credit card. The Symphony Powered Breast Pump employs a control knob, for the user to adjust the applied vacuum. The breast pump is capable of providing vacuum levels from 0 to 200 mmHg, constant or variable; 7 to 110 cycles per minute. Configured with a specific pumping card, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles. All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.
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    K Number
    K984589
    Device Name
    PHOTOTHERAPY LAMP
    Manufacturer
    MEDELA, INC.
    Date Cleared
    1999-04-20

    (117 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medela's phototherapy lamp is intended for the treatment of excessive serumbilirubin concentrations in newborn babies.
    Device Description
    Not Found
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    K Number
    K983552
    Device Name
    BASIC, MEDIAN, DOMINANT, AND VARIO
    Manufacturer
    MEDELA, INC.
    Date Cleared
    1999-01-07

    (90 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Basic, Median, Dominant and Vario Suction Pumps are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
    Device Description
    Not Found
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    K Number
    K962612
    Device Name
    BILIBED PHOTOTHERAPY LAMP
    Manufacturer
    MEDELA, INC.
    Date Cleared
    1996-12-12

    (162 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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