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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 5 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Cpap | 313-7721 | FDA UDI | Class II | Active |
| BiTrac | 10160049 | FDA UDI | Class II | Active |
| 02-Resq | 313-7237X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9037W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9032W | FDA UDI | Class II | Active |
| O2-Max | 313-8017X-13 | FDA UDI | Class II | Active |
| 02-Max | 313-7640X | FDA UDI | Class II | Active |
| O2-Max | 313-7070-7 | FDA UDI | Class II | Active |
| Aero-Sat Filter Compact Straight | 100802 | FDA UDI | Class II | Active |
| Blom | 313-13-100 | FDA UDI | Class II | Active |
| BiTrac SE | 10160056 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9582 | FDA UDI | Class II | Active |
| Blom | 313-00-040 | FDA UDI | Class II | Active |
| Aero-Sat Filter Pedi | 101002 | FDA UDI | Class II | Active |
| DART-Reach | REACH700 | EUDAMEDFDA UDI | Class II | Active |
| VT Select | 7159094 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9518 | FDA UDI | Class II | Active |
| Blom | 313-20-100 | FDA UDI | Class II | Active |
| 02-Resq | 313-7236 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1016 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9566 | FDA UDI | Class II | Active |
| O2-Max | 313-8018 | FDA UDI | Class II | Active |
| 02-Resq | 313-7236X | FDA UDI | Class II | Active |
| BiTrac | 313-9073 | FDA UDI | Class I | Active |
| BiTrac SE MaxShield | 313-9055W | FDA UDI | Class II | Active |
| BiTrac Select | 313-9520 | FDA UDI | Class II | Active |
| 02-Max | 313-7640-2 | FDA UDI | Class II | Active |
| BiTrac | 313-9071 | FDA UDI | Class I | Active |
| BiTrac Select | 313-9533 | FDA UDI | Class II | Active |
| O2-Max | 313-7070-3 | FDA UDI | Class II | Active |
| O2-Resq | 313-5095 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9532 | FDA UDI | Class II | Active |
| 02-Max | 313-8004X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9578A | FDA UDI | Class II | Active |
| O2-Max | 313-7555XN-1 | FDA UDI | Class II | Active |
| BiTrac Select | 10161773 | FDA UDI | Class II | Active |
| Go-Pap | 313-4601N | FDA UDI | Class II | Active |
| BiTrac Select | 313-9504 | FDA UDI | Class II | Active |
| 02-Max | 313-8017-5 | FDA UDI | Class II | Active |
| 02-Max | 313-7655-5 | FDA UDI | Class II | Active |
| 02-Max | 313-7656-2 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9103 | FDA UDI | Class II | Active |
| 02-Max | 313-8107X | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9595 | FDA UDI | Class II | Active |
| O2-Max | 313-7555X-9 | FDA UDI | Class II | Active |
| Blom | 313-71-015 | FDA UDI | Class II | Active |
| BiTrac Select | 10161782 | FDA UDI | Class II | Active |
| BiTrac | 10161576 | FDA UDI | Class II | Active |
| O2-Max | 313-8121-11 | FDA UDI | Class II | Active |
| O2-Max | 313-7556X-9 | FDA UDI | Class II | Active |
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