Question 1

What types of medical devices does Ritedose Pharmaceuticals, LLC manufacture?

Accepted Answer

Ritedose Pharmaceuticals, LLC specializes in sterile inhalation therapy solutions. Their portfolio includes isotonic and hypertonic saline inhalation solutions, as well as sterile water for inhalation. These products are formulated in various concentrations (e.g., 0.45%, 0.7%, 3%, and 10% sodium chloride) and volumes (e.g., 3 mL, 4 mL, 5 mL, and 15 mL), designed for single-use delivery via inhalation devices. The solutions are also available in unit-dose and individually wrapped formats for clinical and home use.

Question 2

Where is Ritedose Pharmaceuticals, LLC based, and what regulatory framework does it follow?

Accepted Answer

Ritedose Pharmaceuticals, LLC is based in the United States. Since its devices are medical products intended for inhalation therapy, they must comply with U.S. regulatory requirements for sterile pharmaceutical-grade solutions. The company adheres to domestic standards to ensure safety, efficacy, and quality for its products.

Question 3

Which regulatory registries list Ritedose Pharmaceuticals, LLC’s devices?

Accepted Answer

Ritedose Pharmaceuticals, LLC’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This database is a key resource for tracking and identifying medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare system.

Question 4

How are Ritedose Pharmaceuticals, LLC’s inhalation therapy devices classified by the FDA?

Accepted Answer

All of Ritedose Pharmaceuticals, LLC’s listed inhalation therapy devices fall under FDA Class II classification. This classification applies to devices that generally pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure their safety and effectiveness, beyond general controls like good manufacturing practices.

Device	Model / Reference	Registries	Class	Status
Sodium Chloride Inhalation Solution, USP, 3.5% 4mL UDV	4 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV	4 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV	5 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped	3 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.7% 4 mL UDV (UOU)	4 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped	5 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV	4 mL	FDA UDI	Class II	Active
Sterile Water for Inhalation, USP, 3 mL UDV	3 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV	3 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL UDV	15 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.45% 5 mL UDV	5 mL	FDA UDI	Class II	Active
Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV	3 mL	FDA UDI	Class II	Active
Sterile Water for Inhalation, USP, 5 mL UDV	5 mL	FDA UDI	Class II	Active

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