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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.

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.

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.

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.

The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Insulated Strap is an accessory to the enFlow IV Fluid Warmer which is used to secure the warmer component of the enFlow IV Fluid Warmer System to the patient during transport. The Insulated strap consists of a silicone strap, an insulating element and a mounting plate, into which the user can secure the enFlow IV Fluid Warmer.

The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/min. The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit. The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.

The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infuscate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min. The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit.

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.

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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.

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1. Warming transfusions, infusions, fluids. 2. Warming blood transfusions and return blood flow.

The ASTOFLO PLUS is a modified version of the ASTOFLO covered by K020060. The ASTOFLO uses the closed water circuit where the temperature of the closed water circuit is controlled by sensors. ASTOFLO PI.US uses dry heat warming and the control the sleeve temperature with integrated sensors. The ASTOFLO PLUS blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Stihler ASTOFLO 510(K) Number 020060 and Barkey Prismacomfort 510(K) Number K071909. The ASTOFLO PLUS blood warmer is used to warm the transfusions, infusions, fluids and also return blood flow in the medical field. The ASTOFLO PLUS warmer consists of one control unit and one sleeve warmer. The control unit (ASTOFLO PLUS) controls the sleeve warmer made by Stihler and displays alarm and status messages. The ASTOFLO PLUS warmer warms blood, infusions, fluids and return blood flow by means of a silicon tube heat exchanger, which covers the fluid lines used in the medical field nearly complete. The heat is transferred by the contact of the resistance heating system to the inserted disposable lines need in the medical field. The nearly complete enclosure of the disposable lines used in the medical field to be warmed ensures that there is good warmth conduction to the fluids and there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the disposable lines used in the medical field and may be used with any therapy choices. when heat loss may cause undesirable cooling of the patient. The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC), 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler ASTOFLO PLUS. Above the on-off switch is a display temperature monitor. The temperature of the sleeve warmer visual and audible alarms and other performance characteristic of the sleeve warmer are controlled electronically. Like the blood warmer Stihler ASTOFLO and the Barkey Prismacomfort, the sleeve warmer Stihler ASTOFLO PLUS is constructed as a slotted enclosed silicon tube, which can completely enclose inserted bluod return flow lines of up to 7.00 mm diameter. The ASTOFLO Plus weighs approx 3.0 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on i.v. poles and medical rails. All three products, the Stihler ASTOFLO PLUS, Barkey Prismacomfort and the Sticker ASTOFI.O use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the disposable lines used in the medical field.

The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The Pak 2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.

Each of the iv fluid warmer devices (Soft Pack, FloorMount and Pak 2) employs a heating plate or heating blanket to warm or maintain the temperature of iv fluids such as normal saline and ringers lactate. These devices use a standard temperature control method and operate reliably in the range of 36-38 degrees C. The Smithworks products are designed to use a 40 watt, 12 VDC with an optional 120 VAC adaptor, for enhanced safety and portability when used in the field. The Thermal Sack Pressure Infuser is an accessory to the Smithworks iv fluid warmer components. This device is wrapped around the iv fluid bag and is used to apply even pressure to the iv fluid bag when it cannot be maintained in the standard hanging state, which applies normal gravity pressure. This device should only be used in conditions that require emergency personnel to move victims in conditions that prevent a normal gravity based suspension of the iv fluid bag, and when the rescue mission is conducted by a limited number of emergency medical personnel.

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.

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.