Search Results
Found 60 results
510(k) Data Aggregation
K Number
K232107Device Name
°M Warmer System
Manufacturer
MEQU A/S
Date Cleared
2024-05-31
(322 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.
Device Description
The °MEQU °M Warmer System consists of three components:
- a single-patient use, disposable warmer unit
- a multi-patient, reusable, rechargeable battery pack for powering the warmer
- a reusable charger for recharging the battery pack.
The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminium heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack.
The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid.
Remaining power in the battery pack is indicated to the user during use. When depleted, the battery pack can be re-charged using the charger.
Ask a Question
K Number
K211618Device Name
Fluido Compact Blood and Fluid Warming System
Manufacturer
The Surgical Company International B.V.
Date Cleared
2023-06-05
(740 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluido Compact Blood and Fluid Warming System can be used in adult patients that need fluid warming pror to administration of blood, blood products and IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.
Device Description
The Fluido® Compact System consists of Fluido Compact Warming Module, Fluido Compact Control Module and Fluido Compact Standard Set (disposable).
The Fluido Compact system is designed to supply warm fluids at 39°C set point with flow rates from 5 to 100 ml/min. The sterile disposable set consist of a plastic housing and biocompatible coated aluminum heater plate. Heat from the warming module is transferred through the heat transfer part into the fluids that is circulating through the inner part of the cassette. The disposable is connected to the blood or fluid source (infusate reservoir) and the patient line on the other end. The disposable has standard luer lock fittings on both ends. The Control Module serves as the power supply for the Warming module.
Fluid and blood are warmed during infusion or transfusion. The delivery of heat is done by heat exchange. A warming module exchanges heat to a disposable set, which is connected to the fluid reservoir and the patient line via conduction warming technology The fluid temperature is controlled by closed loop software and guarded by sensors and has a redundant safety module for fluid overtemperature shutoff.
Ask a Question
K Number
K211800Device Name
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
Manufacturer
Quality in Flow Ltd.
Date Cleared
2022-12-08
(546 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Warrior Blood and Fluid Warmer device is intended for warming blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The Warrior EXTREME Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The Warrior Lite Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
Device Description
The QinFlow Blood and Fluid Warmer (Warrior / Warrior lite) is a portable sterile fluid path, inline blood and fluid warmer intended for warming blood, blood products, and intravenous fluids prior to administration. The device is composed of the following main components:
1. Disposable Unit (DU) / Compact Disposable Unit (CDU)
2. Base Unit (BU)
3. Power source
4. Connecting Cable (CC)
5. The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.
Ask a Question
K Number
K202461Device Name
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Manufacturer
Smisson-Cartledge Biomedical LLC
Date Cleared
2022-08-12
(715 days)
Product Code
LGZ, FPA, FRN
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells [not in additive . solutions and stored up to 21 days with anticoagulants], as volume replacement for patients suffering from blood loss due to trauma or surgery; warmed fluid to rewarm patients after surgery or for hypothermia; warmed fluid for irrigation in urology procedures.
Device Description
The ThermaCor® 1200 Disposable Sets are intended for use only with the Smisson-Cartledge Biomedical (SCB) ThermaCor® 1200 Rapid Thermal Infusion System. The Disposable Sets consist of configurations that include cassettes with tubing connectors, various patient lines, and supply lines capable of interfacing with intravenous (IV) bags or optional-use reservoir equipment. Use of the ThermaCor® 1200 Disposable Sets ensures the intended use of the ThermaCor® 1200 Rapid Thermal Infusion System is met. The ThermaCor® 1200 Disposable Sets are provided sterile, non-pyrogenic and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.
The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is a portable or pole-mounted device intended for use in the hospital emergency room (ER), operating room (OR), intensive care unit (ICU), and Labor and Delivery (L&D) environments.
The system consists of an infusion device and a compatible, single patient use sterile disposable set with supply lines capable of interfacing with intravenous (IV) bags or an optional reservoir. The ThermaCor® 1200 Infuser may be used with a Footswitch (optional accessory) to allow hands-free, user-controlled delivery.
The ThermaCor® 1200 Infuser can deliver flow rates from 10 mL per Hour to 1200 mL per Minute selectable in 10mL/hr in Slow mode and 20mL/min in Rapid mode at normothermic temperatures and is intended for continuous operation. The ThermaCor® 1200 Rapid Thermal Infusion System is driven by a volumetric pump capable of variable-rate continuous infusion up to approximately 100 Liters total volume per Cassette. The system is also capable of delivering discrete bolus infusions. The user can select Bolus Mode to deliver a fixed, predetermined bolus of up to 1 Liter at a default or adjustable rate. When connected to alternating current (AC) power, the ThermaCor® 1200 Infuser can deliver fluids warmed to body temperature under most conditions. The Infuser can also run on battery power (heating capabilities will be disabled) to allow transport of the patient. A lithium-ion battery pack provides the power backup.
Ask a Question
K Number
K213191Device Name
S-Line
Manufacturer
Barkey GmbH & Co. KG
Date Cleared
2022-05-24
(237 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.
Device Description
The Barkey S-line is a blood and infusion fluid warmer. The infused fluid flows through a standard IV set. The IV line is inserted into a groove in a warming sleeve, referred to as the Sline. The warming sleeve is made of silicon with embedded heating wires. There is no direct contact between the heat exchanging tube and the fluids. The fluid only contacts the off-the-shelf 510(k) I.V. extension set. There is no software / firmware in the device. The S-line operates on 100 - 240 VAC. 50/60 Hz powering an IEC 60601-1 compliant internal power supply. The set temperature is set to 39 ℃ which is not user selectable. The fluid is warmed to approximately 39 ℃ as it travels a path through the heating sleeve. The temperature is constantly monitored and adjusted. The temperature is measured at the end of the extension set, where it leaves the heated sleeve prior to delivery to the patient. The S-line unit weighs approximately 1.3 kg and is equipped with a knob clamp at the back of the devices for attachment to an I.V. pole, the S-line may also be clamped to a bedrail. Independent overtemperature protector monitors the temperature in the warming section. In case of a fault, there is a second overtemperature safety feature which if a temperature of 43°C +/- 1°C is reached, the warming section's heater is switched off, the luminous ring in the display and control panel shows yellow and an acoustic alarm sounds.
Ask a Question
K Number
K192325Device Name
Quantum Blood and Fluid Warming System
Manufacturer
Life Warmer, Inc.
Date Cleared
2019-10-18
(52 days)
Product Code
LGZ, BSB, LZG
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum" Blood and Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to administration in adult and pediatic patients greater than 28 days old of normal birth weight. It is intended for use by healthcare professionals in hospital, clinical, field, and transport environments to help prevent hypothermia.
The Quantum is not for use with neonates (birth to 28 days old) or infants of low birth weight.
Device Description
The Quantum Blood and Fluid Warming System is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing laver. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery and Battery Chargers are reusable.
Ask a Question
K Number
K180842Device Name
MAC Medical D-Series Blanket and Solution Warming Cabinets
Manufacturer
MAC Medical Inc.
Date Cleared
2019-03-05
(340 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/ or injection fluids in accordance with the recommended warming temperatures and storage guidelines provided by the manufacturers of such products.
Device Description
The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/ or blankets to an acceptable level for hospital and surgical outpatient center applications.
The MAC Medical D-Series Warming Cabinets are constructed with stainless steel panels, headers and doors. The Warming Cabinets are doubled walled constructed and are fully insulated to provide uniform heating. Optional glass doors are double paned tempered glass with aluminum.
A pull-out shelf inside the top of the cabinet contains the heating element, fan, thermostat, and temperature sensor. The electronics are located on the outside of the cabinet and the power cable is connected in the back of the cabinet. The wheeled baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning and repositioning.
Ask a Question
K Number
K181775Device Name
Quantum Blood and IV Fluid Infusion Warmer
Manufacturer
Life Warmer, Inc.
Date Cleared
2019-01-28
(209 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Blood and IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital. clinical. field and transport environments to help prevent hypothenmia.
Device Description
The Quantum Blood and IV Fluid Infusion Warmer is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the proximal, medial and distal tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing layer. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller and the Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery Chargers are reusable.
Ask a Question
K Number
K180154Device Name
QiF Blood and Fluid Warmer
Manufacturer
Quality In Flow Ltd.
Date Cleared
2018-04-27
(98 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.
Device Description
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components:
1. Disposable Unit (DU) - The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.
2. Base Unit (BU) – The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU or an AC power supply module; the BU contains firmware (SW) and electronics (HW).
3. Connecting Cable (CC) - a cable that connect between the BU and the DU to facilitate the transfer of data and electrical current.
Ask a Question
K Number
K171215Device Name
QiF Blood and Fluid Warmer
Manufacturer
Quality In Flow Ltd.
Date Cleared
2017-09-27
(155 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Product Code :
LGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.
Device Description
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors. 2. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.
Ask a Question
Page 1 of 6