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This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy. This device is not intended for parenteral use or for preparations intended for parenteral use.

The subject device is 3mL or 5 mL Sodium Chloride Inhalation Solution USP, 0.9%. The single-use device is a color-coded (pink) blow-fill-sealed, low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for inhalation therapy (respiratory therapy and tracheal lavage. For respiratory therapy, Sodium Chloride Inhalation Solution USP, 0.9% is used for dilution of solutions used in nebulizers. The product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

The subject devices are 4mL Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%. The single-use devices are a clear blow-fill-sealed, low density polyethylene (LDPE) vials containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. Sodium Chloride Inhalation Solution USP, 3%, 7% or 10% are used in conjunction with a nebulizer. The product contains 3%, 7% or 10% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.