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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 13 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Max | 313-7435X | FDA UDI | Class II | Active |
| O2-Max | 313-8008N-6 | FDA UDI | Class II | Active |
| 02-Resq | 313-7040 | FDA UDI | Class II | Active |
| O2-Cpap | 313-7725 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9543 | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9151 | FDA UDI | Class II | Active |
| O2-Max | 313-7555X-5 | FDA UDI | Class II | Active |
| O2-Resq | 313-7064 | FDA UDI | Class II | Active |
| Adapt-2-Vent | 313-7029C | FDA UDI | Class II | Active |
| O2-Resq | 313-7031 | FDA UDI | Class II | Active |
| O2-Max | 313-7536X-5 | FDA UDI | Class II | Active |
| O2-Max | 313-7537X | FDA UDI | Class II | Active |
| Blom | 313-40-060 | FDA UDI | Class II | Active |
| Blom | 313-10-040 | FDA UDI | Class II | Active |
| O2-Max | 313-7539X-1 | FDA UDI | Class II | Active |
| 02-Max | 313-7638 | FDA UDI | Class II | Active |
| VT Sure | 7151121 | FDA UDI | Class II | Active |
| BiTrac | 313-9002W | FDA UDI | Class II | Active |
| Aero-Pro Filter Small Angled | 200202 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9503 | FDA UDI | Class II | Active |
| O2-Max | 313-8007XN-13 | FDA UDI | Class II | Active |
| 02-Resq | 313-7037X | FDA UDI | Class II | Active |
| O2-Max | 313-7556 | FDA UDI | Class II | Active |
| BiTrac SE | 313-9010W | FDA UDI | Class II | Active |
| BiTrac HC | 313-9406 | FDA UDI | Class II | Active |
| BiTrac SE MaxShield | 313-9056W | FDA UDI | Class II | Active |
| Aero-Sat Filter Compact Angled | 100902 | FDA UDI | Class II | Active |
| O2-Max | 313-8202 | FDA UDI | Class II | Active |
| O2-Max | 313-7555-5 | FDA UDI | Class II | Active |
| Pertrach | 313-D4557 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9101 | FDA UDI | Class II | Active |
| O2-Max | 313-8008 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161771 | FDA UDI | Class II | Active |
| Go-PAP | 313-4604 | FDA UDI | Class II | Active |
| O2-Max | 313-7556X | FDA UDI | Class II | Active |
| O2-Max | 313-7746X-9 | FDA UDI | Class II | Active |
| VT Select | 7159093 | FDA UDI | Class II | Active |
| BiTrac Select | 10161784 | FDA UDI | Class II | Active |
| Blom | 313-12-040 | FDA UDI | Class II | Active |
| O2-Max | 313-7554X | FDA UDI | Class II | Active |
| O2-Resq | 313-5097 | FDA UDI | Class II | Active |
| BiTrac | 313-9007 | FDA UDI | Class II | Active |
| O2-Max | 313-8118X | FDA UDI | Class II | Active |
| O2-Cpap | 313-7719 | FDA UDI | Class II | Active |
| O2-Max | 313-7538XNF | FDA UDI | Class II | Active |
| O2-Max | 313-7534X | FDA UDI | Class II | Active |
| Blom | 313-11-080 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1007 | FDA UDI | Class II | Active |
| Aero-T+ | 301102 | FDA UDI | Class I | Active |
| BiTrac | 10160051 | FDA UDI | Class II | Active |
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