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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 8 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiTrac SE Select | 10161778 | FDA UDI | Class II | Active |
| BiTrac SE MaxShield | 10160046 | FDA UDI | Class II | Active |
| Aero-Sat | 102302 | FDA UDI | Class II | Active |
| 02-Max | 313-8017X-7 | FDA UDI | Class II | Active |
| Blom | 313-12-100 | FDA UDI | Class II | Active |
| Blom | 313-00-080 | FDA UDI | Class II | Active |
| O2-Cpap | 313-7720 | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN | FDA UDI | Class II | Active |
| BiTrac SE | 313-9009W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9034W | FDA UDI | Class II | Active |
| BiTrac Select | 10161774 | FDA UDI | Class II | Active |
| Aero-Pro HEPA Small Angled | 20152 | FDA UDI | Class II | Active |
| O2-Resq | 313-5096 | FDA UDI | Class II | Active |
| 02-Max | 313-7641-8 | FDA UDI | Class II | Active |
| Blom | 313-14-080 | FDA UDI | Class II | Active |
| Go-Pap | 313-4602N | FDA UDI | Class II | Active |
| BiTrac | 313-9014W | FDA UDI | Class II | Active |
| BiTrac | 313-9076 | FDA UDI | Class I | Active |
| O2-Max | 313-7556XN-1 | FDA UDI | Class II | Active |
| O2-Resq | 313-7238X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9561 | FDA UDI | Class II | Active |
| BiTrac MaxShield | 313-9052W | FDA UDI | Class II | Active |
| BiTrac Select | 313-9511 | FDA UDI | Class II | Active |
| O2-Max | 313-7535X | FDA UDI | Class II | Active |
| BiTrac Select | 10161775 | FDA UDI | Class II | Active |
| O2-Max | 313-8007X-11 | FDA UDI | Class II | Active |
| O2-Max | 313-7070-4 | FDA UDI | Class II | Active |
| O2-Max | 313-8007XN-5 | FDA UDI | Class II | Active |
| Blom | 313-20-080 | FDA UDI | Class II | Active |
| O2-Max | 313-8017XN-5 | FDA UDI | Class II | Active |
| Blom | 313-22-080 | FDA UDI | Class II | Unknown |
| 02-Resq | 313-7045 | FDA UDI | Class II | Active |
| Aero-Pro S Filter | 200102 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9535 | FDA UDI | Class II | Active |
| 02-Max | 313-7761-4 | FDA UDI | Class II | Active |
| BiTrac MaxShield | 10160044 | FDA UDI | Class II | Active |
| Go-Pap | 313-4603 | FDA UDI | Class II | Active |
| 02-Max | 313-8014X | FDA UDI | Class II | Active |
| O2-Max | 313-7438X | FDA UDI | Class II | Active |
| BiTrac SE | 10160054 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9062W | FDA UDI | Class II | Active |
| BiTrac Select | 313-9563 | FDA UDI | Class II | Active |
| O2-Max | 313-7556XN | FDA UDI | Class II | Active |
| O2-Resq | 313-7052 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9558 | FDA UDI | Class II | Active |
| O2-Resq | 313-7054 | FDA UDI | Class II | Active |
| 02-Max | 313-7762-8 | FDA UDI | Class II | Active |
| Blom | 313-01-040 | FDA UDI | Class II | Active |
| Blom | 313-20-060 | FDA UDI | Class II | Active |
| Go-PAP | 313-4604NC | FDA UDI | Class II | Active |
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