LIFESTAR PHARMA LLC

Lifestar Pharma LLC specializes in sterile saline inhalation solutions used in respiratory therapy. Their portfolio includes isotonic (0.9%) and hypertonic (3% and 7%) saline formulations, designed specifically for nebulization. These solutions are intended to help with airway hydration, mucus clearance, and respiratory treatment, adhering to USP standards for inhalation use.

Lifestar Pharma LLC is based in the United States. Their inhalation therapy saline solutions are manufactured for use within the U.S. regulatory environment, where they are classified as medical devices under FDA oversight.

Lifestar Pharma LLC’s inhalation therapy saline solutions fall under Class II medical device classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as labeling requirements or performance standards.

Yes, Lifestar Pharma LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details, such as manufacturer information and device specifications.