Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K040286
    Device Name
    ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
    Manufacturer
    ETHOX CORP.
    Date Cleared
    2004-03-15

    (38 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHOX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A non-sterile disposable inflatable bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.
    Device Description
    The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs consists of a cuff bladder manufactured from polyester reinforced vinyl. The cuff is closed with a hook and loop fastening system (Velcro Loop with vinyl backing and YKK PVC hook). The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are disposable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC or Nylon) for use with most monitoring systems.
    Ask a Question
    K Number
    K031195
    Device Name
    CUF-COVER (TM)
    Manufacturer
    ETHOX CORP.
    Date Cleared
    2003-10-10

    (177 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHOX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.
    Device Description
    This device is a cover for blood pressure cuffs. It is made non-woven polypropylene with a polyethylene coating. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.
    Ask a Question
    K Number
    K962850
    Device Name
    TUM-E-VAC
    Manufacturer
    ETHOX CORP.
    Date Cleared
    1997-02-21

    (214 days)

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

    ETHOX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Comparable to single tube Gastric lavage and stomach evacuator tubes. Disposable, non-sterile tube for gastric lavage. The lavage tube is used as a two way conduit from a lavage bag set to the stomach.
    Device Description
    The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage. The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action.
    Ask a Question

    Page 1 of 1