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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 6 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiTrac | 313-9015W | FDA UDI | Class II | Active |
| 02-Max | 313-8006X | FDA UDI | Class II | Active |
| DART-Reach | REACH720 | EUDAMEDFDA UDI | Class II | Active |
| 02-Resq | 313-7235 | FDA UDI | Class II | Active |
| 02-Max | 313-8016X | FDA UDI | Class II | Active |
| Blom | 313-22-060 | FDA UDI | Class II | Active |
| O2-Max | 313-7535X-5 | FDA UDI | Class II | Active |
| BiTrac | 313-9016W | FDA UDI | Class II | Active |
| O2-Max | 313-7556XNF-1 | FDA UDI | Class II | Active |
| 02-Max | 313-7655-7 | FDA UDI | Class II | Active |
| 02-Resq | 313-7035X | FDA UDI | Class II | Active |
| BiTrac SE Shield | 313-9051W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9063W | FDA UDI | Class II | Active |
| BiTrac HC | 313-9403 | FDA UDI | Class II | Active |
| 02-Resq | 313-7356X | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9154 | FDA UDI | Class II | Active |
| O2-Max | 313-8017N-6 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9506 | FDA UDI | Class II | Active |
| Blom | 313-10-100 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9509 | FDA UDI | Class II | Active |
| Go-PAP | 313-4602NC | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN-6 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9572 | FDA UDI | Class II | Active |
| Bacterial/Viral Depth Filter no Port | 313-435 | FDA UDI | Class II | Active |
| Go-PAP | 313-4605N | FDA UDI | Class II | Active |
| VT Sure | 7151111 | FDA UDI | Class II | Active |
| BiTrac | 313-9004W | FDA UDI | Class II | Active |
| 02-Resq | 313-7256 | FDA UDI | Class II | Active |
| Blom | 313-10-080 | FDA UDI | Class II | Active |
| O2-Max | 313-8017N-4 | FDA UDI | Class II | Active |
| O2-Max | 313-7536X | FDA UDI | Class II | Active |
| Blom | 313-30-100 | FDA UDI | Class II | Active |
| Dpm | 313-5558 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9530 | FDA UDI | Class II | Active |
| O2-Max | 313-7554XN | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN-14 | FDA UDI | Class II | Active |
| 02-Max | 313-7662-4 | FDA UDI | Class II | Active |
| 02-Max | 313-7476 | FDA UDI | Class II | Active |
| BiTrac Select | 10161765 | FDA UDI | Class II | Active |
| 02-Max | 313-7655X-5 | FDA UDI | Class II | Active |
| Blom | 313-11-100 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9508 | FDA UDI | Class II | Active |
| O2-Max | 313-8001X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9514 | FDA UDI | Class II | Active |
| Blom | 313-14-060 | FDA UDI | Class II | Active |
| Aero-Pro HEPA Small Angled | 20151 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9597 | FDA UDI | Class II | Active |
| O2-Max | 313-8018XN | FDA UDI | Class II | Active |
| BiTrac Select | 313-9502 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9110 | FDA UDI | Class II | Active |
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