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Found 12 results
510(k) Data Aggregation
K Number
K112639Device Name
THE BELMONT BUDDY LITE FLUID WARMER
Manufacturer
BELMONT INSTRUMENT CORP.
Date Cleared
2011-11-16
(65 days)
Product Code
BSB
Regulation Number
864.9205Why 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
K090508Device Name
THE BELMONT BUDDY LITE FLUID WARMER
Manufacturer
BELMONT INSTRUMENT CORP.
Date Cleared
2009-03-26
(28 days)
Product Code
BSB
Regulation Number
864.9205Why 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
K062774Device Name
BELMONT BUDDY PLUS FLUID WARMER
Manufacturer
BELMONT INSTRUMENT CORP.
Date Cleared
2006-10-19
(31 days)
Product Code
BSB, 81B
Regulation Number
864.9205Why 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
K052547Device Name
BELMONT BUDDY FLUID WARMER
Manufacturer
BELMONT INSTRUMENT CORP.
Date Cleared
2005-10-13
(27 days)
Product Code
BSB, 81B
Regulation Number
864.9205Why 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
K031478Device Name
MICROHEATER
Manufacturer
BELMONT INSTRUMENT CORP.
Date Cleared
2003-07-02
(51 days)
Product Code
BSB, 81B, LGZ
Regulation Number
864.9205Why 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
K020060Device Name
ASTOFLO
Manufacturer
NATS CORP.
Date Cleared
2002-03-05
(56 days)
Product Code
BSB, LGZ
Regulation Number
864.9205Why 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
K012031Device Name
MODIFICATION TO THERMAL ANGEL
Manufacturer
ESTILL MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-07-26
(28 days)
Product Code
BSB
Regulation Number
864.9205Why 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
K991159Device Name
PRISMATHERM II, ASTOLINE
Manufacturer
STIHLER ELECTRONIC GMBH
Date Cleared
1999-09-03
(149 days)
Product Code
BSB
Regulation Number
864.9205Why 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
K991160Device Name
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
Manufacturer
STIHLER ELECTRONIC GMBH
Date Cleared
1999-09-02
(148 days)
Product Code
BSB
Regulation Number
864.9205Why 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
K984640Device Name
THERMAL ANGEL
Manufacturer
ESTILL MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-07-01
(182 days)
Product Code
BSB
Regulation Number
864.9205Why 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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