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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 11 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiTrac Vented | 313-9156 | FDA UDI | Class II | Active |
| 02-Max | 313-7641X-7 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9571 | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9152 | FDA UDI | Class II | Active |
| O2-Max | 313-8118 | FDA UDI | Class II | Active |
| O2-Max | 313-7070-1 | FDA UDI | Class II | Active |
| Aero-Sat | 000702 | FDA UDI | Class I | Active |
| BiTrac Select | 10161767 | FDA UDI | Class II | Active |
| Areo-Pro | 200302 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9068W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9030W | FDA UDI | Class II | Active |
| O2-Max | 313-8007XNF-1 | FDA UDI | Class II | Active |
| Bitrac SE Select | 313-9537 | FDA UDI | Class II | Active |
| BiTrac SE | 10160055 | FDA UDI | Class II | Active |
| Aero-Sat Filter Compact Straight | 100801 | FDA UDI | Class II | Active |
| O2-Max | 313-8007N-5 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9501 | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9153 | FDA UDI | Class II | Active |
| Control-Cric | 313-4567 | FDA UDI | Class II | Active |
| O2-Max | 313-7538XN-1 | FDA UDI | Class II | Active |
| O2-Max | 313-7557X | FDA UDI | Class II | Active |
| O2-Max | 313-8012X-5 | FDA UDI | Class II | Active |
| 02-Max | 313-8001X-5 | FDA UDI | Class II | Active |
| O2-Max | 313-7555XNF-1 | FDA UDI | Class II | Active |
| O2-Max | 313-7070-2 | FDA UDI | Class II | Active |
| O2-Max | 313-8007XN-14 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9415 | FDA UDI | Class II | Active |
| BiTrac Select | 10161833 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161772 | FDA UDI | Class II | Active |
| 02-Max | 313-8019X-9 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9067W | FDA UDI | Class II | Active |
| O2-Max | 313-7555XNF | FDA UDI | Class II | Active |
| BiTrac HC | 313-9401 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1014 | FDA UDI | Class II | Active |
| Pertrach | 313-D4553 | FDA UDI | Class II | Active |
| O2-Max | 313-7745X-9 | FDA UDI | Class II | Active |
| Blom | 313-14-040 | FDA UDI | Class II | Active |
| O2-Resq | 313-7266 | FDA UDI | Class II | Active |
| 02-Max | 313-7655-1 | FDA UDI | Class II | Active |
| 02-Max | 313-8011X | FDA UDI | Class II | Active |
| 02-Max | 313-8117X | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN-5B | FDA UDI | Class II | Active |
| VT Select | 313-5590 | FDA UDI | Class II | Active |
| 02-Max | 313-7640 | FDA UDI | Class II | Active |
| O2-Max | 313-7557XNF-1 | FDA UDI | Class II | Active |
| Blom | 313-10-060 | FDA UDI | Class II | Active |
| Aero-Sat HEPA | 102902 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9601 | FDA UDI | Class II | Active |
| Adapt-2-Vent | 313-7030S | FDA UDI | Class II | Active |
| 02-Max | 313-7657 | FDA UDI | Class II | Active |
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