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510(k) Data Aggregation

    K Number
    K013200
    Device Name
    RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
    Date Cleared
    2001-12-14

    (80 days)

    Product Code
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENNELS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Contami-Shield ™ Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. For Single Patient Use.
    Device Description
    The Contami-Shield Breathing Circuit Sleeve, indicated for use with mechanicallyventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. The disclosed device is an external device, not in physical contact with the patient, intended for use with ventilators, anesthesia machines, and open flow systems where the external protection of the breathing circuit is desired. The disclosed device shall be slipped over the external surface of the breathing circuit prior to use. A filter or HME filter may be changed or removed from the breathing circuit, while the Contami-Shield is present and in use, if desired.
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