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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.

This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.

A nasal CPAP mask that is used with positive airway pressure equipment recommended by a physician, sleep technician, or respiratory therapist.

The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

In the treatment of sleep disorders, CPAP is well established and common practice as a means to prevent upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. There are a number of devices legally marketed in the United States for this application, including self-adjusting CPAP systems such as the predicate ResMed Sullivan Autoset T. The self-adjusting systems accommodate pressure requirements that may vary (e.g., as patients change bodies positions or enter different sleep stages). The Breas PV10i CPAP is similar to the predicate Breas PV100 CPAP System, but with the addition of self-adjusting pressure features. Both Breas devices are microprocessor controlled based on firmware (embedded software). Both designs incorporate pressure sensors that monitor output pressure and provide feedback to the microprocessors. The PV10i also incorporates an airflow sensor and flow signal processing means in firmware to provide self-adjusting capability. The therapy delivered by the Breas PV10i CPAP System can be either: - 1) Self-adjusting in response to variations in patient breathing patterns (CPAP "i" mode), or - 2) Set to a constant pressure level (constant CPAP mode). The primary hardware component is a blower that generates airflow. The blower assembly consists of a brushless DC motor that drives a fan, entraining ambient air through a filter and pressurizing it to provide the prescribed airflow with CPAP for the patient. The microprocessor controls the motor and hence the speed of the fan. The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription. The CPAP airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the minimum output pressure setting of 4 cm of H20 are recommended for use with the PV10i. The pressure transducer incorporated in the PV10i continuously monitors output pressure to the patient and reference ambient pressure. This enables the device to automatically compensate for altitude changes. The PV10i has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12 - 24 VDC power source when AC mains line voltage is not available. This DC power source capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance. The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.

The Disposable Pressure Manometer will be used to provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.

The VSI disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: A flexible nipple for attachment to a sampling/pressure port, Clear polycarbonate (PC) housing with a printed pressure scale, PC float with indication and a double ended stainless steel spring.

The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ adapter, sheath, and base stand that is intended for use with standard luer-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-Lok™ adapter engages with the sheath, preventing needle exposure.

The device description of the Sure-Lok™ secondary needle kit is as follows. - Hypodermic single lumen needle, 20G 25G, 5/8" to 1½" length. u - Adapter attached to needle with 6% (luer) taper for syringe barrel . attachment. - Needle Sheath that seals the needle tip and locks with the adapter to I prevent needle exposure. - . Base Stand that holds the sheath in an upright position during engagement of the needle and sheath. - Individually packaged and sterilized. l