Is this your brand? Sign in to claim ownership.
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 2 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiTrac Select | 313-9531 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9028W | FDA UDI | Class II | Active |
| O2-Max | 313-7533XN-5B | FDA UDI | Class II | Active |
| BiTrac Select | 313-9555 | FDA UDI | Class II | Active |
| 02-Max | 313-7655-3 | FDA UDI | Class II | Active |
| 02-Max | 313-8015X | FDA UDI | Class II | Active |
| Aero-Pro HEPA Light Machine | 201022 | FDA UDI | Class II | Active |
| Go-Pap | 313-4604N | FDA UDI | Class II | Active |
| 02-Max | 313-7642 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9512 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9581 | FDA UDI | Class II | Active |
| O2-Max | 313-8007XN-5B | FDA UDI | Class II | Active |
| O2-Max | 313-7457X | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9546 | FDA UDI | Class II | Active |
| Go-PAP | 313-4605NC | FDA UDI | Class II | Active |
| O2-Max | 313-7756X | FDA UDI | Class II | Active |
| AccuPAP | 313-6000 | FDA UDI | Class II | Active |
| O2-Max | 313-8005X | FDA UDI | Class II | Active |
| 02-Resq | 313-7033X | FDA UDI | Class II | Active |
| Pertrach | 313-D4551 | FDA UDI | Class II | Active |
| O2-Max | 313-8000 | FDA UDI | Class II | Active |
| Aero-Sat HEPA | 102901 | FDA UDI | Class II | Active |
| BiTrac | 313-9075 | FDA UDI | Class I | Active |
| O2-Max | 313-7556X-1 | FDA UDI | Class II | Active |
| O2-Resq | 313-5094 | FDA UDI | Class II | Active |
| BiTrac HC | 313-9102 | FDA UDI | Class II | Active |
| O2-Max | 313-7557XN | FDA UDI | Class II | Active |
| O2-Max | 313-7556XNF | FDA UDI | Class II | Active |
| 02-Resq | 313-7037 | FDA UDI | Class II | Active |
| O2-Max | 313-8008X-5B | FDA UDI | Class II | Active |
| 02-Resq | 313-7233 | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9551 | FDA UDI | Class II | Active |
| BiTrac | 313-9001W | FDA UDI | Class II | Active |
| BiTrac SE Select | 313-9538 | FDA UDI | Class II | Active |
| 02-Resq | 313-7257 | FDA UDI | Class II | Active |
| BiTrac SE | 313-9011W | FDA UDI | Class II | Active |
| Dpm | 313-5559 | FDA UDI | Class II | Active |
| 02-Max | 313-8003X | FDA UDI | Class II | Active |
| BiTrac Select | 313-9576 | FDA UDI | Class II | Active |
| Bitrac HC | 313-9411 | FDA UDI | Class II | Active |
| BiTrac Select | 313-9594 | FDA UDI | Class II | Active |
| 02-Max | 313-7656-7 | FDA UDI | Class II | Active |
| Blom | 313-22-100 | FDA UDI | Class II | Active |
| O2-Max | 313-7557XN-4 | FDA UDI | Class II | Active |
| O2-Max | 313-7555XN-5B | FDA UDI | Class II | Active |
| O2-Max | 313-7533X | FDA UDI | Class II | Active |
| Pro-Fit | 313-1020 | FDA UDI | Class II | Active |
| Dart | DART140 | EUDAMEDFDA UDI | Class I | Active |
| BiTrac Select | 313-9578 | FDA UDI | Class II | Active |
| 02-Max | 313-8008X-5 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.