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Sign in to claim this brandWhat BREAS MEDICAL, INC. makes
The company manufactures home-use continuous positive airway pressure (CPAP) units, portable electric ventilators, and nurse call system alarms for hospital environments. It also produces reusable ventilator breathing circuits, utility trolleys for medical equipment, and electrical cables—including reusable medical device connection cables and mains power cables. Secondary batteries for portable ventilators are part of the portfolio, alongside a nurse call alarm system for patient monitoring.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States and adheres to applicable regulatory standards for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- hdmusa.com
- —
- —
- [email protected]
- Phone
- 855-436-8729
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079296736
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vivo 45 LS | 008436 | FDA UDI | Class II | Active |
| Human Design Medical | US | FDA UDI | Class II | Active |
| Vivo 45 LS, Vivo 65 | 006361 | FDA UDI | Class II | Active |
| Vivo 1/2, Vivo 3 | 004465 | FDA UDI | Class I | Active |
| Vivo 45 LS, Vivo 65 | 006360 | FDA UDI | Class II | Active |
| Vivo 45 LS | 007103 | FDA UDI | Class II | Active |
| Vivo 45 LS | 006709 | FDA UDI | Class II | Active |
| Breas Vivo 40 System | US | FDA UDI | Class II | Unknown |
| Vivo 65 | 006435 | FDA UDI | Class II | Active |
| Human Design Medical | US | FDA UDI | Class II | Active |
| Human Design Medical | US | FDA UDI | Class II | Active |
| Vivo 50 | 004898 | FDA UDI | Class II | Active |
| Vivo 1/2, Vivo 3 | 007006 | FDA UDI | Class II | Active |
| Ventilator Trolley | 007858 | FDA UDI | Class I | Active |
| Vivo 50, Vivo 65 | 004899 | FDA UDI | Class II | Active |
| Vivo 45 LS | 007732 | FDA UDI | Class II | Active |
| Vivo 50, Vivo 65, Vivo 45 LS | 005032 | FDA UDI | Class II | Active |
| Vivo 50 | 007219 | FDA UDI | Class II | Active |
| Vivo 50 | 005429 | FDA UDI | Class II | Unknown |
| Human Design Medical | US | FDA UDI | Class II | Active |
| Human Design Medical | US | FDA UDI | Class II | Active |
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