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510(k) Data Aggregation

    K Number
    K231256
    Device Name
    Carecube Negative Pressure Isolation Chamber
    Manufacturer
    Date Cleared
    2024-01-03

    (247 days)

    Product Code
    Regulation Number
    880.5450
    Why did this record match?
    Product Code :

    LGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.
    Device Description
    The Carecube Negative Pressure Isolation Chamber is a modular, negative pressure, isolation patient care system with both reusable and disposable components that can rapidly augment capacity to care for airborne infectious diseases and other biological threats for common patient care protocols with features built into the unit to allow ease of execution. The device is intended to be used indoors, in a hospital setting, as a temporary isolation of patients with suspected or confirmed diagnosis of infectious disease to prevent Healthcare Practitioners (HCP) exposure to pathogenic biological airborne particulates and is designed with features that enable low-moderate complexity medical interventions.
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    K Number
    K163223
    Device Name
    ORCA (tm) - Operational Rescue Containment Apparatus
    Date Cleared
    2017-11-02

    (351 days)

    Product Code
    Regulation Number
    880.5450
    Why did this record match?
    Product Code :

    LGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.
    Device Description
    The Operational Rescue Containment Apparatus (ORCATM) Patient Isolation Unit, Model ORCA-2016CN, is a tubular, flexible, Patient Isolation Unit (PIU) for use during transport and evacuation of chemical and particulate (biological and radiological) contaminated patients who have been medically stabilized. Each unit employs clear windows to allow visual monitoring of the patient. The unit incorporates multiple glove arms for minimal medical intervention. The PIU's have a reinforced base mat with integrated carry straps and tethers to enable lifting and attachment to a Stokes litter for hoisting operations or a North Atlantic Treaty Organization (NATO) litter for alternative transportation. Chamber airflow through the isolator and across the patient is provided by the blower from a Powered Air-Purifying Respirator (PAPR). Internal contaminated air in the PIU is vented out the exhaust ports which are fitted with two Chemical, Biological, Radiological, Nuclear (CBRN) filter cartridges, thus protecting the external environment from a contaminated patient.
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    K Number
    K080117
    Device Name
    PATIENT ISOLATION UNIT, MODEL G019-1000
    Manufacturer
    Date Cleared
    2009-01-30

    (379 days)

    Product Code
    Regulation Number
    880.5450
    Why did this record match?
    Product Code :

    LGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment. The PIU is intended to be used as a means to temporarily isolate a contaminated patient , outside or within patient care facilities. The PIU can also be used to transport those patients within vehicles, including aircraft, via a NATO-type or similar litter/gumey.
    Device Description
    The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment.
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    K Number
    K022260
    Device Name
    FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
    Date Cleared
    2002-08-29

    (62 days)

    Product Code
    Regulation Number
    880.5450
    Why did this record match?
    Product Code :

    LGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For Transporting and Isolating a TB patient or a suspected TB patient
    Device Description
    Not Found
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