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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 3 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DART-Reach | REACH600 | EUDAMEDFDA UDI | Class II | Active |
| O2-Max | 313-8007N-6 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9577A | FDA UDI | Class II | Active |
| 02-Max | 313-8119-11 | FDA UDI | Class II | Active |
| O2-Max | 313-7000-2 | FDA UDI | Class II | Active |
| 02-Max | 313-8018X | FDA UDI | Class II | Active |
| BiTrac | 313-9003W | FDA UDI | Class II | Active |
| BiTrac Select | 313-9542 | FDA UDI | Class II | Active |
| Go-Pap | 313-4603N | FDA UDI | Class II | Active |
| O2-Max | 313-7538XNF-1 | FDA UDI | Class II | Active |
| O2-Max | 313-7555X | FDA UDI | Class II | Active |
| 02-Max | 313-7655X-7 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9044W | FDA UDI | Class II | Active |
| BiTrac | 10160052 | FDA UDI | Class II | Active |
| O2-Max | 313-8201-6 | FDA UDI | Class II | Active |
| 02-Max | 313-7074-7 | FDA UDI | Class II | Active |
| 02-Max | 313-8012X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9593A | FDA UDI | Class II | Active |
| Aero-Sat | 000602 | FDA UDI | Class I | Active |
| O2-Max | 313-7538XN-2 | FDA UDI | Class II | Active |
| O2-Max | 313-8121-7 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9536 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1008 | FDA UDI | Class II | Active |
| O2-Max | 313-8117X-11 | FDA UDI | Class II | Active |
| TrachVox | 313-1000 | FDA UDI | Class II | Active |
| VT Sure | 7153131 | FDA UDI | Class II | Active |
| VT Select | 7159091 | FDA UDI | Class II | Active |
| 02-Resq | 313-7355X | FDA UDI | Class II | Active |
| O2-Max | 313-7557XN-1 | FDA UDI | Class II | Active |
| Dart | DART110 | EUDAMEDFDA UDI | Class I | Active |
| Hmef | 1341902 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9577 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9556 | FDA UDI | Class II | Active |
| Blom | 313-50-080 | FDA UDI | Class II | Active |
| Aero-Pro HEPA Light w/Port | 201002 | FDA UDI | Class II | Active |
| BiTrac | 313-9615 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9524 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9525 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9583 | FDA UDI | Class II | Active |
| O2-Max | 313-8000-8 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9410 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9593 | FDA UDI | Class II | Active |
| 02-Resq | 313-7041 | FDA UDI | Class II | Active |
| Aero-Pro Filter Small Straight | 200602 | FDA UDI | Class II | Active |
| Blom | 313-00-060 | FDA UDI | Class II | Active |
| 02-Max | 313-8007-5 | FDA UDI | Class II | Active |
| Blom | 313-20-040 | FDA UDI | Class II | Active |
| Go-Pap | 313-4602 | FDA UDI | Class II | Active |
| Aero-Pro HEPA Small Straight | 20162 | FDA UDI | Class II | Active |
| 02-Max | 313-7655-8 | FDA UDI | Class II | Active |
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