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510(k) Data Aggregation

    K Number
    K132890
    Device Name
    SUPRAPUBIC CATHETER AND INTRODUCER SET
    Manufacturer
    MEDIPLUS LTD.
    Date Cleared
    2014-01-17

    (123 days)

    Product Code
    KOB
    Regulation Number
    876.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPLUS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.
    Device Description
    Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip, The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire
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    K Number
    K131339
    Device Name
    CAPNOMASK
    Manufacturer
    MEDIPLUS LTD.
    Date Cleared
    2013-11-25

    (200 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPLUS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. Environment of use - hospital and sub-acute settings. Patient population - Non-intubated patients who are breathing spontaneously.
    Device Description
    The proposed Capnomask design is like a standard oxygeu mask with a port for connecting a gas sampling line which is then to be comected to a gas monitor to measure exhaled carbon dioxide. The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to counect a standard gas sampling line. In addition, it has air entrainment holes to supply room air if needed. It is available in sizes ranging from large to snuall, similar to the predicate device.
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    K Number
    K031617
    Device Name
    MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
    Manufacturer
    MEDIPLUS LTD.
    Date Cleared
    2004-01-16

    (238 days)

    Product Code
    KLA
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPLUS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mediplus Single Use Anorectal GI Manometry Catheter is intended for waterperfused manometry of the anorectal GI tract. The Mediplus Single Use Anorectal GI Manometry catheter is indicated for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders. The product is for use by a trained physician.
    Device Description
    Mediplus Single Use Anorectal GI Manometry Catheters are designed for the monitoring of anorectal canal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Anorectal GJ Manometry Catheter is a multilumen PVC tube. The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the anorectal gastrointestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.
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    K Number
    K013704
    Device Name
    MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
    Manufacturer
    MEDIPLUS LTD.
    Date Cleared
    2002-08-05

    (270 days)

    Product Code
    KLA
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPLUS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mediplus Single Use GI Manometry Catheter is intended for water-perfused manometry of the GI tract. The Mediplus Single Use & Manometry Catheter is inducation for use when measurements of gastrointestinal tract pressures are needed for the diagnosis of suspected gastrointestinal disonders : - Investigation of gastrantestinal diseases - motility dison - Swallowing disorders - Refury disorders - Gastric and intestine disorders - Coloniec and anorectal disorders
    Device Description
    Mediblus GI Motility Manometric Catheters are design for the monitoring of gastrointestinal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Manometric Catheter is a multi-lumen PVC tube. The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the upper gastro-intestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.
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