ARCHEON

Archeon specializes in manual pulmonary resuscitators, which are devices used to assist with emergency resuscitation by providing ventilation to patients. Their portfolio includes both reusable and single-use models. Additionally, they produce related accessories such as battery chargers (e.g., EOlife Charger), control units (e.g., EOlife ECU), and monitoring devices (e.g., EOlife BP) to support respiratory support systems. These devices are designed to aid in critical care scenarios where manual ventilation is required.

Archeon is based in the United States. Their devices, including manual pulmonary resuscitators and related accessories, fall under the FDA’s regulatory classification system. Specifically, these devices are classified as Class II, which typically requires premarket notification (510(k)) clearance before they can be marketed in the U.S. Additionally, Archeon’s products are listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance with regulatory requirements.

Archeon’s devices are included in the FDA’s regulatory databases, specifically through the 510(k) pathway for premarket clearance and the Unique Device Identifier (UDI) system for tracking and compliance. These registries ensure that their manual pulmonary resuscitators and associated accessories meet FDA requirements before being marketed. The UDI system, in particular, helps streamline device identification and recall processes.

Under FDA regulations, Archeon’s manual pulmonary resuscitators are classified as Class II devices. This classification is based on their intended use in emergency resuscitation, where they provide critical ventilation support. Class II devices generally require a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet safety and effectiveness standards before commercial distribution.

Archeon manufactures both single-use and reusable manual pulmonary resuscitators, catering to different clinical and operational needs. Single-use models are designed for one-time use, reducing the risk of cross-contamination and simplifying disposal in emergency settings. Reusable models, on the other hand, are built for repeated use with proper cleaning and maintenance, offering cost efficiency for facilities with high resuscitation demands. The choice between the two depends on factors like infection control protocols, budget constraints, and operational workflows.