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510(k) Data Aggregation

    K Number
    K112639
    Device Name
    THE BELMONT BUDDY LITE FLUID WARMER
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Date Cleared
    2011-11-16

    (65 days)

    Product Code
    BSB
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
    Device Description
    Not Found
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    K Number
    K090508
    Device Name
    THE BELMONT BUDDY LITE FLUID WARMER
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Date Cleared
    2009-03-26

    (28 days)

    Product Code
    BSB
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
    Device Description
    Not Found
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    K Number
    K062774
    Device Name
    BELMONT BUDDY PLUS FLUID WARMER
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Date Cleared
    2006-10-19

    (31 days)

    Product Code
    BSB, 81B
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    buddy plus™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
    Device Description
    The Belmont buddy plus™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit. The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.
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    K Number
    K052547
    Device Name
    BELMONT BUDDY FLUID WARMER
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Date Cleared
    2005-10-13

    (27 days)

    Product Code
    BSB, 81B
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    buddy™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
    Device Description
    The Belmont buddy™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module and a disposable set. The power module powers the heater unit and displays alarm and status messages, and a disposable set which is placed in the heater unit and through which the fluid flows. The heating technology used is resistive heating of two plates within the heater unit. The buddy™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of flow, or empty set, and a number of internal fault conditions such as electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The device provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a standard IV infusion set at its output. The input can come from a bag or supplied via a standard clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low flow applications where the flow rate is 6 liter/hour (100 ml/min) or less. This premarket application describes a modification to the disposable set.
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    K Number
    K031478
    Device Name
    MICROHEATER
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Date Cleared
    2003-07-02

    (51 days)

    Product Code
    BSB, 81B, LGZ
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microheater intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia. The system is not meant for the infusion of drugs, or platelet or granulocyte suspensions.
    Device Description
    The Belmont Microheater is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The heating technology used is resistive heating of two plates within the heater unit. The Microheater warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty cartridge, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The Microheater is not meant to be used with pressurized infusers. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.
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    K Number
    K020060
    Device Name
    ASTOFLO
    Manufacturer
    NATS CORP.
    Date Cleared
    2002-03-05

    (56 days)

    Product Code
    BSB, LGZ
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: - 1. Warming transfusions, infusions, fluids. - 2. Warming blood infusions and return blood flow.
    Device Description
    Not Found
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    K Number
    K012031
    Device Name
    MODIFICATION TO THERMAL ANGEL
    Manufacturer
    ESTILL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-07-26

    (28 days)

    Product Code
    BSB
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermal Angel™ model 200 Blood/Fluid Warmer is Indicated for the warming of blood, blood products and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in clinical and field environments. Thermal Angel™ model 200 Blood and Fluid Warmer is an in-line, intravenous blood and fluid warmer. Thermal Angel™ is indicated for use whenever introduction of normothermic, parenteral (intravenous or irrigation) fluids are desired or indicated, whether in field or clinical settings.
    Device Description
    The Thermal Angel™ model 200 Blood/Fluid Warmer consists of a single unit that is placed The Themal Angel - The set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous fluics at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures of 38°C (100.4°F). While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly and within seconds, to 38℃ (100.4°F). Thermal Angel's™ fluid path is sterile and nonpyrogenic, and the entire warming unit is disposable after use. Thermal Angel™ is battery operated, powered by a 12V DC system. Blood, blood and intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.
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    K Number
    K991159
    Device Name
    PRISMATHERM II, ASTOLINE
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Date Cleared
    1999-09-03

    (149 days)

    Product Code
    BSB
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Warm return blood flow
    Device Description
    Not Found
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    K Number
    K991160
    Device Name
    ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Date Cleared
    1999-09-02

    (148 days)

    Product Code
    BSB
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow
    Device Description
    Astotherm Plus, Astotubes, Astoline
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    K Number
    K984640
    Device Name
    THERMAL ANGEL
    Manufacturer
    ESTILL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-07-01

    (182 days)

    Product Code
    BSB
    Regulation Number
    864.9205
    Why did this record match?
    Product Code :

    BSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermal Angel™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic fluids are desired or indicated, whether in field or clinical settings.
    Device Description
    The Thermal Angel™ 200 Blood/Fluid Warmer consists of a single unit that is placed in-line between a standard IV drip set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures at 38°C. While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly, and within seconds, to 38°C. Thermal Angel's™ fluid path is sterile and the entire unit is disposable after use. Blood, blood products or intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by means of electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.
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