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This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.

The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.

The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extend the patient interface away from the nebulizer. The accessory is a single patient is intended to be used with either mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.

The corrugated tube with mouthpiece accessory is designed to work in conjunction with the cleared predicate device, MC300 * Nebulizer (K173367) to extend the patient interface away from the nebulizer. In line with FDA's definition of a "medical device accessory", the corrugated tube with mouthpiece accessory is intended to supplement the performance of the parent device, MC300* Nebulizer (K173367). The principle of operation of MC300* Nebulizer remains the same as cleared under K173367.

The AeroEclipse* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The subject device. AeroEclipse* ONE BAN (Breath Actuated Nebulizer) is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, thus significantly reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home. Liquid medication is placed in the medication cup of the nebulizer bottom, into which the nebulizer top sub-assembly is attached. The air supply tubing provides the interface for the pressurized air. Aerosol is inhaled by the patient via the oral interface of the mouthpiece. As the patient inhales, ambient air travels down through the nebulizer, creating a pressure drop which causes the actuator, connected to the diaphragm to move down into the nebulizing position. As inhalation continues, aerosol is created and inhaled through the mouthpiece. When inhalation ceases, the actuator returns to the up position thereby eliminating the pressure drop which leads to the device discontinuing the creation of an aerosol. As the patient inhales through the mouthpiece, the actuator drops, and the creation of aerosol begins again. The overall device is comprised of a nebulizer bottom with nozzle feature, a nebulizer top sub-assembly, a mouthpiece and air supply tubing.

The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 - 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.

The Aerobika® OPEP device and VersaPAP™ device can be used independently or combined. When combined for ease of use. The combined device creates oscillations during the exhalation phase (OPEP) to aid in secretion clearance and during the inhalation phase (PAP) helps to maintain positive airway pressure for the treatment and prevention of atelectasis.

The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home. It is a single patient, multiple use device.

The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a holding chamber used for the administration of aerosolized medications. The AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products is designed to be used with a broad range of FDA approved pressurized metered dose inhaler (pMDI) or soft mist inhaler (SMI) pharmaceutical formulations prescribed by a healthcare provider. It is a single patient, multi-use device intended to be used by patients who are under the care or treatment of a licensed health care professional. This device is not used with a specific drug nor is it distributed with such drugs.

VersaPAP* is indicated for the treatment and prevention of atelectasis. VersaPAP* also has the ability to provide supplemental oxygen when used with compressed oxygen. The VersaPAP* device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway in a hospital environment. The VersaPAP* device is a single patient, multiple use device intended to be used under the supervision of a healthcare professional.

The VersaPAP* device is a hand held respiratory therapy device that creates a positive airway pressure. The VersaPAP* device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The VersaPAP* device is a single patient use device and may be used for two treatments per day for 7 days. A manometer gauge is included to monitor airway pressure while operating the VersaPAP* device. The VersaPAP* device consists of seven components: a mouthpiece, the VersaPAP* backpiece (includes 3 components: the baffle, body and end cap), a manometer adapter, a manometer gauge, and oxygen tubing.

The nebulizer is intended to be used with pediatic (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

The MC 300*R Nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system. The device is intended to be used by pediatric (ages 2 years and above) and adult patients in hospital, clinic or home settings. The MC 300*R Nebulizer is a single patient use device and may be used for multiple treatments. This device is not used with a specific drug nor is it distributed with such drugs. The MC 300*R Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300*R Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the reorder information on the IFU.

The nebulizer is intended to be used with pediatic (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

The MC 300* Nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system. The device is intended to be used by pediatric (ages 2 years and above) and adult patients in hospital, clinic or home settings. The MC 300* Nebulizer is a single patient use device and may be used for multiple treatments. This device is not used with a specific drug nor is it distributed with such drugs. The MC 300* Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300* Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the information on the IFU.

The Aerobika* Oscillating Positive Expiratory Pressure device intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.

The Aerobika* OPEP with Manometer device combines Positive Expiratory Pressure (PEP) with oscillations upon exhalation with visual feedback relative to the patient's expiratory pressure. The device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure. The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

The RespiConnect Adapter is designed to be used with RESPIMAT™ SOFT MIST INHALERS to facilitate the delivery of bronchodilator aerosol medication to mechanically ventilated patients. The single patient use adapter is intended to be left in the inspiratory limb of a 22 mm ventilator circuit.

The RespiConnect Adapter is a single-patient use device intended to provide a self-sealing access port in a ventilator circuit to facilitate the administration of Respimat™ Soft Mist inhaler medication to mechanically ventilated patients.