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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 10 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Max | 313-8007XN-2 | FDA UDI | Class II | Active |
| Aero-Pro | 201012 | FDA UDI | Class II | Active |
| O2-Max | 313-8038N-13 | FDA UDI | Class II | Active |
| BiTrac SE NaxShield | 10160048 | FDA UDI | Class II | Active |
| Aero-Pro HEPA Light | 201011 | FDA UDI | Class II | Active |
| 02-Resq | 313-7034 | FDA UDI | Class II | Active |
| O2-Max | 313-7556X-5 | FDA UDI | Class II | Active |
| O2-Max | 313-7539XN | FDA UDI | Class II | Active |
| BiTrac Select | 313-9527 | FDA UDI | Class II | Active |
| O2-Max | 313-8007XN | FDA UDI | Class II | Active |
| 02-Max | 313-8020X-9 | FDA UDI | Class II | Active |
| 02-Max | 313-7762-4 | FDA UDI | Class II | Active |
| BiTrac MaxShield | 313-9054W | FDA UDI | Class II | Active |
| BiTrac Select | 10161832 | FDA UDI | Class II | Active |
| 02-Max | 313-8002X | FDA UDI | Class II | Active |
| Pro-Fit | 313-1004 | FDA UDI | Class II | Active |
| BiTrac | 313-9616 | FDA UDI | Class II | Active |
| O2-Max | 313-8201X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9596 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9031W | FDA UDI | Class II | Active |
| BiTrac SE MaxShield | 10160047 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161783 | FDA UDI | Class II | Active |
| O2-Max | 313-8018X-5 | FDA UDI | Class II | Active |
| O2-Resq | 313-7029 | FDA UDI | Class II | Active |
| 02-Resq | 313-7237 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9568 | FDA UDI | Class II | Active |
| O2-Max | 313-8008XN-1 | FDA UDI | Class II | Active |
| Blom | 313-40-080 | FDA UDI | Class II | Active |
| Blom | 313-50-040 | FDA UDI | Class II | Active |
| O2-Max | 313-7556X-2 | FDA UDI | Class II | Active |
| O2-Max | 313-7533XN-5B | FDA UDI | Class II | Active |
| BiTrac Select | 313-9513 | FDA UDI | Class II | Active |
| VT Sure | 7153111 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9562 | FDA UDI | Class II | Active |
| O2-Max | 313-7070 | FDA UDI | Class II | Active |
| BiTrac | 313-9613 | FDA UDI | Class II | Active |
| Go-Pap | 313-4601 | FDA UDI | Class II | Active |
| 02-Max | 313-7641X | FDA UDI | Class II | Active |
| O2-Max | 313-7461 | FDA UDI | Class II | Active |
| 02-Resq | 313-7234X | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9553 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9576A | FDA UDI | Class II | Active |
| 02-Max | 313-7761-8 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9507 | FDA UDI | Class II | Active |
| 02-Resq | 313-7055 | FDA UDI | Class II | Active |
| 02-Max | 313-7641-2 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9409 | FDA UDI | Class II | Active |
| Aero-Sat | 000102 | FDA UDI | Class I | Active |
| BiTrac Select | 10161766 | FDA UDI | Class II | Active |
| VT Sure | 7152131 | FDA UDI | Class II | Active |
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