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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 7 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiTrac Select | 313-9559 | FDA UDI | Class II | Active |
| 02-Resq | 313-7046 | FDA UDI | Class II | Active |
| 02-Max | 313-8007X-5 | FDA UDI | Class II | Active |
| O2-Max | 313-8017N-5 | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9155 | FDA UDI | Class II | Active |
| 02-Max | 313-7656X-4 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9590 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9048W | FDA UDI | Class II | Active |
| VT Sure | 7152111 | FDA UDI | Class II | Active |
| BiTrac Vented | 313-9150 | FDA UDI | Class II | Active |
| Go-PAP | 313-4600 | FDA UDI | Class II | Active |
| O2-Cpap | 313-7730 | FDA UDI | Class II | Active |
| O2-Max | 313-7533X-5 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9567 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161777 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9047W | FDA UDI | Class II | Active |
| O2-Max | 313-8018-13 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161770 | FDA UDI | Class II | Active |
| BiTrac | 313-9013W | FDA UDI | Class II | Active |
| BiTrac | 10160050 | FDA UDI | Class II | Active |
| 02-Max | 313-7656X-1 | FDA UDI | Class II | Active |
| Blom | 313-01-100 | FDA UDI | Class II | Active |
| Blom | 313-50-100 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9515 | FDA UDI | Class II | Active |
| 02 Max | 313-7640X-8 | FDA UDI | Class II | Active |
| 02-Resq | 313-7039 | FDA UDI | Class II | Active |
| Pertrach | 313-D4558 | FDA UDI | Class II | Active |
| O2-Max | 313-7539-1 | FDA UDI | Class II | Active |
| O2-CPAP Valve | 313-7717 | FDA UDI | Class II | Active |
| 02-Max | 313-7655 | FDA UDI | Class II | Active |
| O2-Resq | 313-7238 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9111 | FDA UDI | Class II | Active |
| 02-Max | 313-7641X-8 | FDA UDI | Class II | Active |
| O2-Max | 313-7490X | FDA UDI | Class II | Active |
| Blom | 313-30-080 | FDA UDI | Class II | Active |
| BiTrac | 10161578 | FDA UDI | Class II | Active |
| O2-Max | 313-8000-5 | FDA UDI | Class II | Active |
| O2-Max | 313-8007XNF | FDA UDI | Class II | Active |
| 02-Max | 313-7640X-4 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9602 | FDA UDI | Class II | Active |
| BiTrac SE Select | 10161785 | FDA UDI | Class II | Active |
| 02-Max | 313-8013X | FDA UDI | Class II | Active |
| BiTrac MaxShield | 10160045 | FDA UDI | Class II | Active |
| 02-Resq | 313-7234 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9414 | FDA UDI | Class II | Active |
| VT Select | 313-5593 | FDA UDI | Class II | Active |
| O2-Max | 313-8007X-13 | FDA UDI | Class II | Active |
| BiTrac SE | 313-9012W | FDA UDI | Class II | Active |
| Blom | 313-30-060 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9100 | FDA UDI | Class II | Active |
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