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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 4 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 02-Resq | 313-7036X | FDA UDI | Class II | Active |
| Blom | 313-11-060 | FDA UDI | Class II | Active |
| Pertrach | 313-D4554 | FDA UDI | Class II | Active |
| VT Select | 313-5592 | FDA UDI | Class II | Active |
| BiTrac SE | 10160053 | FDA UDI | Class II | Active |
| 02-Max | 313-7656X | FDA UDI | Class II | Active |
| BiTrac Select | 10161780 | FDA UDI | Class II | Active |
| O2-Max | 313-7070-8 | FDA UDI | Class II | Active |
| 02-Resq | 313-7038X | FDA UDI | Class II | Active |
| Blom | 313-50-060 | FDA UDI | Class II | Active |
| O2-Max | 313-8108 | FDA UDI | Class II | Active |
| 02-Resq | 313-7036 | FDA UDI | Class II | Active |
| O2-Max | 313-8007N-4 | FDA UDI | Class II | Active |
| Pertrach | 313-D4555 | FDA UDI | Class II | Active |
| Dart | DART100 | EUDAMEDFDA UDI | Class I | Active |
| Aero-Sat Filter Compact Angled | 100901 | FDA UDI | Class II | Active |
| 02-Max | 313-8008X | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161776 | FDA UDI | Class II | Active |
| O2-Max | 313-7554XN-1 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9412 | FDA UDI | Class II | Active |
| O2-Max | 313-8120 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9523 | FDA UDI | Class II | Active |
| 02-Resq | 313-7049 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9599 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9408 | FDA UDI | Class II | Active |
| 02-Resq | 313-7034X | FDA UDI | Class II | Active |
| Aero-Pro HEPA Small Straight | 20161 | FDA UDI | Class II | Active |
| 02-Resq | 313-7360X | FDA UDI | Class II | Active |
| BiTrac | 313-9005 | FDA UDI | Class II | Active |
| O2-Max | 313-7538X-1 | FDA UDI | Class II | Active |
| Blom | 313-70-000 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1003 | FDA UDI | Class II | Active |
| 02-Max | 313-8008-4 | FDA UDI | Class II | Active |
| Blom | 313-01-060 | FDA UDI | Class II | Active |
| Aero-Sat Filter Small Angled | 102402 | FDA UDI | Class II | Active |
| O2-Cpap | 313-7715 | FDA UDI | Class II | Active |
| BiTrac Select | 10161779 | FDA UDI | Class II | Active |
| ValueTrac | 313-9078 | FDA UDI | Class I | Active |
| 02-Max | 313-8017X | FDA UDI | Class II | Active |
| BiTrac Select | 10161830 | FDA UDI | Class II | Active |
| O2-Max | 313-8007X-7 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9066W | FDA UDI | Class II | Active |
| BiTrac MaxShield | 313-9057W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9042W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9043W | FDA UDI | Class II | Active |
| O2-Max | 313-8200 | FDA UDI | Class II | Active |
| 02-Resq | 313-7362X | FDA UDI | Class II | Active |
| Pro-Fit | 313-1001 | FDA UDI | Class II | Active |
| O2-Max | 313-8018X-5B | FDA UDI | Class II | Active |
| 02-Resq | 313-7240 | FDA UDI | Class II | Active |
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