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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 12 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 02-Max | 313-8007X-4 | FDA UDI | Class II | Active |
| VT Select | 313-5594 | FDA UDI | Class II | Active |
| VT Sure | 7151131 | FDA UDI | Class II | Active |
| O2-Max | 313-7555XN-4 | FDA UDI | Class II | Active |
| BiTrac | 313-9074 | FDA UDI | Class I | Active |
| BiTrac Select | 313-9573 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9033W | FDA UDI | Class II | Active |
| Hmef | 1333002 | FDA UDI | Class II | Active |
| BiTrac | 313-9085 | FDA UDI | Class II | Active |
| 02-Resq | 313-7256X | FDA UDI | Class II | Active |
| O2-Resq | 313-7030 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161769 | FDA UDI | Class II | Active |
| 02-Max | 313-7661-4 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1006 | FDA UDI | Class II | Active |
| O2-Max | 313-7555XN | FDA UDI | Class II | Active |
| 02-Resq | 3137035 | FDA UDI | Class II | Active |
| 02-Max | 313-7656 | FDA UDI | Class II | Active |
| O2-Max | 313-7556-5 | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN-13 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9598 | FDA UDI | Class II | Active |
| Blom | 313-40-040 | FDA UDI | Class II | Active |
| O2-Resq | 313-7063 | FDA UDI | Class II | Active |
| O2-Max | 313-7554XNF-1 | FDA UDI | Class II | Active |
| 02-Resq | 313-7255 | FDA UDI | Class II | Active |
| 02-Max | 313-7441 | FDA UDI | Class II | Active |
| O2-Max | 313-7555X-2 | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9157 | FDA UDI | Class II | Active |
| 02-Max | 313-7762-7 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1017 | FDA UDI | Class II | Active |
| Blom | 313-13-040 | FDA UDI | Class II | Active |
| 02-Max | 313-7641-4 | FDA UDI | Class II | Active |
| VT Select | 7159092 | FDA UDI | Class II | Active |
| O2-Max | 313-7556XN-4 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1002 | FDA UDI | Class II | Active |
| 02-Resq | 313-7041X | FDA UDI | Class II | Active |
| Pro-Fit | 313-1013 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9548 | FDA UDI | Class II | Active |
| Blom | 313-40-100 | FDA UDI | Class II | Active |
| Aero-Sat Micro+ 3.5 | 001202 | FDA UDI | Class I | Active |
| BiTrac Select | 313-9036W | FDA UDI | Class II | Active |
| 02-Resq | 313-7267 | FDA UDI | Class II | Active |
| O2-Max | 313-7555XN-2 | FDA UDI | Class II | Active |
| 15mmF / 30mmM Adapter | 313-8184 | FDA UDI | Class I | Active |
| BiTrac Select | 313-9035W | FDA UDI | Class II | Active |
| Aero-Sat Filter Small Straight | 102301 | FDA UDI | Class II | Active |
| 02-Max | 313-7655-2 | FDA UDI | Class II | Active |
| 02-Max | 313-7641 | FDA UDI | Class II | Active |
| Aero-Sat Micro+ 3.0 | 001102 | FDA UDI | Class I | Active |
| O2-Max | 313-7456X | FDA UDI | Class II | Active |
| 02-Max | 3138007X-6 | FDA UDI | Class II | Active |
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