Lifestream Pharma

Lifestream Pharma specializes in oropharyngeal mucosa protection materials, which are designed to safeguard the throat and mouth tissues during medical procedures. These materials help minimize irritation and trauma, particularly during interventions like intubation or airway management. The company’s primary focus is on products like the bioXtra line, which fall under this category.

Lifestream Pharma is headquartered in the United States. Its devices are classified under Class U (Unclassified) in the U.S. regulatory system, meaning they are not assigned a traditional risk class but are still subject to regulatory oversight. This classification is determined by the FDA based on the device’s intended use and potential risks.

Yes, Lifestream Pharma’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.

In the U.S., Lifestream Pharma’s devices are classified as Class U (Unclassified). This classification is used for products that do not fit neatly into the standard Class I, II, or III risk categories but still require oversight. The FDA assigns this classification based on factors like the device’s intended use, potential risks, and whether it poses minimal or moderate risk to patients.