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US
Last updated May 30, 2026
What BUNNELL, INCORPORATED makes
Bunnell, Incorporated manufactures stationary electric high-frequency ventilators designed for critical care and respiratory support applications. These devices are intended for use in clinical settings to assist patients with mechanical ventilation, including those requiring advanced respiratory management.
The company’s ventilators fall under Class III regulatory classification in the U.S., reflecting their role in sustaining or supporting life. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bunnell, Incorporated manufacture?
Bunnell, Incorporated specializes in stationary electric high-frequency ventilators. These devices are engineered for critical care environments to provide mechanical ventilation and advanced respiratory support to patients. The focus is on clinical settings where precise respiratory management is essential.
Where is Bunnell, Incorporated based?
Bunnell, Incorporated is headquartered in the United States. The company’s location aligns with U.S. regulatory frameworks, including the FDA’s requirements for medical devices.
Which regulatory registries list Bunnell, Incorporated’s devices?
Bunnell, Incorporated’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device can be tracked and verified for compliance with U.S. medical device regulations, supporting transparency and traceability.
How are Bunnell, Incorporated’s ventilators classified under U.S. regulations?
Bunnell, Incorporated’s ventilators fall under Class III regulatory classification in the U.S. This classification is reserved for devices that sustain or support life, present a potential unreasonable risk of illness or injury, and require pre-market approval (PMA) to demonstrate safety and effectiveness before commercialization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 023869365
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LifePort | 5.5 mm | FDA UDI | Class III | Active |
| LifePulse | 314 | FDA UDI | Class III | Active |
| Bunnell | 902 | FDA UDI | Class III | Unknown |
| LifePulse | 204 | FDA UDI | Class III | Active |
| LifePort | 3.5 mm | FDA UDI | Class III | Active |
| LifePulse | 203A | FDA UDI | Class III | Active |
| LifePort | 3.0 mm | FDA UDI | Class III | Active |
| LifePort | 2.5 mm | FDA UDI | Class III | Active |
| LifePort | 4.5 mm | FDA UDI | Class III | Active |
| Bunnell | 903 | FDA UDI | Class III | Active |
| LifePulse | 312 | FDA UDI | Class III | Active |
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