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PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4

The proposed inhaled saline solutions are in 0.9%, 3%, 3.5%, 6%, 7%, and 10% concentrations with a pH of 7.4. They are packaged sterile in 4 ml vials for use as indicated.

The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.

The NESSI is a spacer intended for use in the inhalations which are provided by OTC MDIs. The device consists of a translucent housing a back piece and mouth piece or face mask. It is a single patient, multi-use device.

PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

PharmaCaribe Sodium Chloride Solutions are homogeneous mixtures (complete solutions) and are composed of USP sterile water and sodium chloride only and provided in 3%, 3.5%, 6%, 7%, and 10% concentrations. They are packaged sterile in standard 5ml (4ml fill) flexible material vials. The vials have a tear-off top. They are marked NOT FOR INJECTION.

The NESSI Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.

The NESSI is a spacer intended for use in the inhalation of MDIs for the therapy of the upper and lower respiratory system. The device consists of a translucent housing a back piece and mouth piece. The NESSI Spacer can be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances: - · Corticosteroids (anti-inflammatory medications) - · Anti-cholinergics and ß2-sympathomimetics (bronchodilater medications) - · Non-steroidal chromones (DNCG) It is a single patient, multi-use device.