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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 9 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Max | 313-8018N-6 | FDA UDI | Class II | Active |
| BiTrac | 10161579 | FDA UDI | Class II | Active |
| 02-Max | 313-7656-5 | FDA UDI | Class II | Active |
| 02-Max | 313-7655X | FDA UDI | Class II | Active |
| O2-Cpap | 313-7716 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161781 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9039W | FDA UDI | Class II | Active |
| BiTrac | 313-9072 | FDA UDI | Class I | Active |
| O2-Max | 313-8007XN-6 | FDA UDI | Class II | Active |
| BiTrac Select | 10161831 | FDA UDI | Class II | Active |
| 02-Max | 313-7761-7 | FDA UDI | Class II | Active |
| 02-Resq | 313-7243 | FDA UDI | Class II | Active |
| 02-Max | 313-7656X-5 | FDA UDI | Class II | Active |
| BiTrac | 313-9070 | FDA UDI | Class I | Active |
| BiTrac HC | 313-9400 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9049W | FDA UDI | Class II | Active |
| O2-Max | 313-8008XN | FDA UDI | Class II | Active |
| Blom | 313-13-080 | FDA UDI | Class II | Active |
| Blom | 313-13-060 | FDA UDI | Class II | Active |
| 02-Max | 313-8108X | FDA UDI | Class II | Active |
| O2-Max | 313-8018N-13 | FDA UDI | Class II | Active |
| BiTrac Select | 10161768 | FDA UDI | Class II | Active |
| O2-Resq | 313-7028 | FDA UDI | Class II | Active |
| 02-Resq | 313-7055-5 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1019 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9580 | FDA UDI | Class II | Active |
| Blom | 3113-00-100 | FDA UDI | Class II | Active |
| 02-Max | 313-7641X-4 | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN-1 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9557 | FDA UDI | Class II | Active |
| O2-Max | 313-7556XN-2 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9405 | FDA UDI | Class II | Active |
| BiTrac SE MaxShield | 313-9053W | FDA UDI | Class II | Active |
| VT Sure | 7154111 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9064W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9547 | FDA UDI | Class II | Active |
| BiTrac | 313-9008 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9407 | FDA UDI | Class II | Active |
| O2-Resq | 313-7030C | FDA UDI | Class II | Active |
| BiTrac Select | 313-9552 | FDA UDI | Class II | Active |
| Blom | 313-22-040 | FDA UDI | Class II | Active |
| Pertrach | 313-D4550 | FDA UDI | Class II | Active |
| Aero-T | 300102 | FDA UDI | Class I | Active |
| O2-Max | 313-8003XN | FDA UDI | Class II | Active |
| 02-Resq | 313-7235X | FDA UDI | Class II | Active |
| 02-Max | 313-8017X-5 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1018 | FDA UDI | Class II | Active |
| 02-Max | 313-7485 | FDA UDI | Class II | Active |
| Pro-Fit | 313-1005 | FDA UDI | Class II | Active |
| Blom | 313-11-040 | FDA UDI | Class II | Active |
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