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Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected. In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient. The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.

The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.

The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.

The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice. The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt). This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled. The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.

The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and regulate the pressure within the PneuX P.Y.TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.

The Venner™ Tracheal Seal Monitor consists of an automatic inflation cuff controller (control unit) that connects to the Venner™ PneuX P.Y.TM Endotracheal or Tracheostomy Tube using a single patient use, sterile extension tube. The Venner™ Tracheal Seal Monitor regulates and maintains cuff pressure in endotracheal and tracheostomy tubes in adult patients in the intensive care unit (ICU) setting. The device is intended to measure, monitor and maintain a stable cuff pressure in endotracheal and tracheostomy tubes. The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms.

The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-clectronic) stethoscope. In addition, the Noble Anesthesia-Air Snor-Scope Plus Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia care professional. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.

The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope System is a kit comprised of the following components: - Audio amplifier module and microphone - Plastic T-connector / diaphragm coupler assembly (airway adapter) - Single Plastic coupler (stethoscope adapter) - Stethoscope Head (standard mechanical acoustic) - Stethoscope (standard mechanical acoustic) - Wall charger (UL listed, medical grade) and eight (8) batteries (rechargeable) A shielded microphone and audio cable, with a 3.5mm plug, connects the microphone/coupler assembly to the amplifier module. The speaker volume may be adjusted on the audio amplifier module to allow comfortable listening levels of breathing sounds passing through the airway circuit for Anesthesia Physicians and Clinical Personnel. A standard stethoscope ear piece may also be used for private listening purposes, although it does not provide the same amplification as in electronic stethoscope mode. The Snor-Scope Plus T-connector is composed of a plastic diaphragm and connector cap which holds the diaphragm tightly in place. This T-connector serves as an attachment for either the manual stethoscope (without head) or to the electronic stethoscope microphone. The device is not sterile, is outside the surgical field, and is a single-use disposable accessory. A single plastic medical grade coupler may also be used as an interface between the Snor-Scope Plus microphone and standard stethoscope dual-diaphragm head for the same purpose that would otherwise require an acoustic (non-electronic) stethoscope. The Noble Anesthesia-Air Electronic Stethoscope provides 20 times greater signal amplitude than a standard acoustic stethoscope. The overall frequency response is 15 - 1500 Hertz. This stethoscope is a stand-alone unit, has no software, and operates using an analog audio system without introducing any signals or energy into the patient or anesthesia breathing circuit. The Amplifier Module is powered by rechargeable Nickel Cadmium Batteries which can be easily replaced. The charger consists of a medical grade UL listed wall adapter. The batteries and charger are of the overall packaged kit. The audio amplifier module controls charging which cannot be performed during use of the Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope.