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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 1 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Max | 313-7555 | FDA UDI | Class II | Active |
| Blom | 313-30-040 | FDA UDI | Class II | Active |
| Go-PAP | 313-4603NC | FDA UDI | Class II | Active |
| Blom | 313-12-080 | FDA UDI | Class II | Active |
| O2-Max | 313-7538XN | FDA UDI | Class II | Active |
| O2-Max | 313-7538X | FDA UDI | Class II | Active |
| O2-Max | 313-7555X-1 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9402 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9109 | FDA UDI | Class II | Active |
| 02-Max | 313-8119-7 | FDA UDI | Class II | Active |
| VT Select | 313-5591 | FDA UDI | Class II | Active |
| VT Sure | 7153121 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9541 | FDA UDI | Class II | Active |
| O2-Cpap | 313-7718 | FDA UDI | Class II | Active |
| O2-Max | 313-7554XNF | FDA UDI | Class II | Active |
| BiTrac Shield | 313-9050W | FDA UDI | Class II | Active |
| 02-Max | 313-8011X-5 | FDA UDI | Class II | Active |
| Blom | 313-01-080 | FDA UDI | Class II | Active |
| Pertrach | 313-D4552 | FDA UDI | Class II | Active |
| AccuPAP | 313-6001 | FDA UDI | Class II | Active |
| 02-Max | 313-7656-1 | FDA UDI | Class II | Active |
| 02-Max | 313-7656-8 | FDA UDI | Class II | Active |
| Pertrach | 313-D4559 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9413 | FDA UDI | Class II | Active |
| Blom | 313-12-060 | FDA UDI | Class II | Active |
| O2-Max | 313-7755X | FDA UDI | Class II | Active |
| 02-Max | 313-8131X | FDA UDI | Class II | Active |
| O2-Max | 313-7539XN-1 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9104 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9516 | FDA UDI | Class II | Active |
| Aero-Pro Filter Compact Angled | 200402 | FDA UDI | Class II | Active |
| BiTrac MaxShield | 10160043 | FDA UDI | Class II | Active |
| O2-Resq | 313-7032 | FDA UDI | Class II | Active |
| 02-Resq | 313-7255X | FDA UDI | Class II | Active |
| O2-Max | 313-8009-5 | FDA UDI | Class II | Active |
| BiTrac | 10161577 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9554 | FDA UDI | Class II | Active |
| 02-Max | 313-7657-8 | FDA UDI | Class II | Active |
| 02-Resq | 313-7038 | FDA UDI | Class II | Active |
| BiTrac | 313-9006 | FDA UDI | Class II | Active |
| Dart | DART300 | EUDAMEDFDA UDI | Class I | Active |
| 02-Resq | 313-7033 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9526 | FDA UDI | Class II | Active |
| 02-Resq | 313-7048 | FDA UDI | Class II | Active |
| Blom | 313-71-000 | FDA UDI | Class II | Active |
| 02-Max | 313-7656-3 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9404 | FDA UDI | Class II | Active |
| VT Sure | 7152121 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9517 | FDA UDI | Class II | Active |
| O2-Max | 313-7554XN-4 | FDA UDI | Class II | Active |
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