Perma Pure, LLC

Perma Pure, LLC specializes in single-use medical devices for respiratory applications. Their primary products include gas-sampling and monitoring respiratory tubing, as well as heated respiratory humidifiers. These devices often incorporate Nafion-based dryer assemblies and modular components, such as dryer configurations, tubing extensions, and sampling lines, which are used to remove moisture from medical gas delivery systems—commonly found in ventilators and anesthesia circuits.

Perma Pure, LLC is headquartered in the United States. The company’s location influences its regulatory compliance with U.S. authorities like the FDA, as well as its participation in global registries like eudamed for EU market access.

Perma Pure, LLC’s devices are listed in multiple key regulatory databases, including the EU’s eudamed registry for transparency in the European market, the FDA’s 510(k) clearance registry (for Class II devices), and the FDA’s Unique Device Identifier (UDI) database, which tracks device identification for post-market surveillance and traceability.

Perma Pure, LLC’s devices fall under Class I and Class II classifications, depending on their intended use and associated risk. Class I devices generally pose minimal risk (e.g., simple tubing), while Class II devices may involve higher-risk functions (e.g., moisture removal systems in critical gas delivery). Classification determines regulatory pathways, such as FDA’s 510(k) clearance requirement for Class II products.