BreathDirect
BreathDirect developed the BDR-19 critical-care ventilator, a US-manufactured, ICU-capable mechanical ventilator authorized for emergency use by the U.S. FDA. The device is designed for full-spectrum invasive and non-invasive ventilatory support with an emphasis on simplicity, portability, rapid producibility, and compliance with medical-device standards. The company partners with U.S. contract manufacturers and suppliers to support assembly-line scale-up and supply-chain resiliency.
Industries
Nr. of Employees
small (1-50)
BreathDirect
Products
BDR-19 critical-care ventilator
An ICU-capable mechanical ventilator designed to provide a full continuum of invasive and non-invasive respiratory support with an emphasis on simple tactile controls, portability, and maintainability.
BDR-19
The BreathDirect BDR-19 is a critical care ventilator designed to meet FDA 510K standards, featuring invasive and non-invasive ventilation modes including PRVC, PC-CMV, and BPAP-S/T.
BDR-19 critical-care ventilator
An ICU-capable mechanical ventilator designed to provide a full continuum of invasive and non-invasive respiratory support with an emphasis on simple tactile controls, portability, and maintainability.
BDR-19
The BreathDirect BDR-19 is a critical care ventilator designed to meet FDA 510K standards, featuring invasive and non-invasive ventilation modes including PRVC, PC-CMV, and BPAP-S/T.
Services
Customer demonstrations, product information, and sales inquiries coordinated via the company contact channels and request-a-demo form.
Customer demonstrations, product information, and sales inquiries coordinated via the company contact channels and request-a-demo form.
Expertise Areas
- Mechanical ventilator design
- Critical care ventilation
- Human factors engineering for medical devices
- Regulatory compliance and emergency-use authorization
Key Technologies
- Multimode mechanical ventilation (BPAP, PRVC, PC-CMV)
- Internal oxygen blender (FiO2 control)
- Tactile rotary knob interface with color-coded LEDs
- Universal patient circuit compatibility
News & Updates
Company press release announcing FDA Emergency Use Authorization and readiness for production.
FDA issued Emergency Use Authorization for the BDR-19 critical-care ventilator.
Company press release announcing FDA Emergency Use Authorization and readiness for production.
FDA issued Emergency Use Authorization for the BDR-19 critical-care ventilator.