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510(k) Data Aggregation

    K Number
    K153719
    Device Name
    LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
    Manufacturer
    HONEYWELL HOMMED, LLC
    Date Cleared
    2016-06-03

    (158 days)

    Product Code
    DRG, BZH, DPS, DQA, DXN, FLL, FRI, GJS, NBW, NXB, OUG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONEYWELL HOMMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface. LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages. LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.
    Device Description
    LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.
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    K Number
    K112858
    Device Name
    GENESIS TOUCH SYSTEM
    Manufacturer
    HONEYWELL HOMMED, LLC
    Date Cleared
    2012-01-24

    (116 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONEYWELL HOMMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs include noninvasive blood pressure, pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmitted.via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional. The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by adult and pediatric patients over twelve years of age or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-of-limit parameters.
    Device Description
    The Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System uses text and voice prompts to help the user acquire vital signs information. Once all data is collected, it is forwarded at the user's discretion, as a data packet to a central viewing station for retrospective review by a healthcare provider. The Genesis Touch Retrospective Physiological Monitoring System is intended for use with adult and pediatric patients over twelve years of age. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring.
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    K Number
    K101242
    Device Name
    GENESIS DM MODEL: 6053000A1
    Manufacturer
    HONEYWELL HOMMED, LLC
    Date Cleared
    2010-06-11

    (39 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONEYWELL HOMMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.
    Device Description
    The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.
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    K Number
    K072272
    Device Name
    HONEYWELL HOMMED CENTRAL STATION 4.0
    Manufacturer
    HONEYWELL HOMMED, LLC
    Date Cleared
    2007-09-07

    (23 days)

    Product Code
    DXN, DYN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONEYWELL HOMMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Central Station's intended use is to retrospectively receive; display and store monitored vital signs parameters and related data. Central Station displays the data and system alerts for review and evaluation by a healthcare professional. Central Station is not intended for emergency use or real-time monitoring.
    Device Description
    Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. Central Station accepts data from Honeywell HomMed Patient Monitors (e.g. Sentry and Genesis) as well as the Honeywell HomMed MedPartner.
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    K Number
    K061087
    Device Name
    GENESIS OTC MONITOR
    Manufacturer
    HONEYWELL HOMMED, LLC
    Date Cleared
    2006-06-09

    (52 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONEYWELL HOMMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.
    Device Description
    The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, and weight. The Genesis OTC Monitor has four serial ports available for external options. The Genesis OTC Monitor acquires vital signs data and displays it. The data can also be transmitted via the communication system to a central viewing station.
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    K Number
    K061088
    Device Name
    SENTRY OTC MONITOR
    Manufacturer
    HONEYWELL HOMMED, LLC
    Date Cleared
    2006-06-09

    (52 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONEYWELL HOMMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Honeywell HomMed Sentry OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oral temperature and weight. Data from optional commercial stand-alone products extend the Sentry OTC Monitor's measurement capabilities. Data from the Sentry OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Sentry OTC Monitor is not intended for emergency use or real-time monitoring.
    Device Description
    The Honeywell HomMed Sentry OTC Monitor is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature and weight. The Sentry OTC Monitor has six serial ports available for external options. The Sentry OTC Monitor acquires the vital signs data and displays it. The data can be transmitted via the communication module to a central viewing station.
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