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Sign in to claim this brandPulmodyne Inc.
United States·US-MF-000017334
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2055, Executive Drive, Indianapolis, United States
- Website
- engmedsys.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Tamara Lefevers
- EUDAMED SRN
- US-MF-000017334
- FDA FEI Number
- 1832562
- DUNS Number
- —
Catalogue (661)
Page 14 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Max | 313-8017X-11 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9040W | FDA UDI | Class II | Active |
| Blom | 313-14-100 | FDA UDI | Class II | Active |
| 02-Max | 313-7638X | FDA UDI | Class II | Active |
| Hmef | 1332402 | FDA UDI | Class II | Active |
| BiTrac | 313-9614 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1015 | FDA UDI | Class II | Active |
| Pertrach | 313-D4556 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9041W | FDA UDI | Class II | Active |
| Hmef | 1331302 | FDA UDI | Class II | Active |
| Pulmodyne Chf Flow Generator System | K080256 | FDA 510(k) | Class II | Active |
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