Is this your brand? Sign in to claim ownership.
Sign in to claim this brandParagonix Technologies, Inc.
United States·US-MF-000038585
Last updated September 17, 2026
About
Advanced organ preservation technology designed to securely transport donor organs.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 950, Winter Street, North, Waltham, United States
- Website
- www.paragonixtechnologies.com/
- linkedin.com/company/paragonix
- facebook.com/paragonixsherpa
- [email protected]
- Phone
- (781) 428-4153
- PRRC Contact
- Randy Koester
- EUDAMED SRN
- US-MF-000038585
- FDA FEI Number
- 3011175555
- DUNS Number
- —
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BAROguard | PRGNX-7007-003-003 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-003 | FDA UDI | Class II | Unknown |
| BAROguard | PRGNX-7007-003-002 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-001 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-000-004 | FDA UDI | Class II | Active |
| LUNGguard | PRGNX-5005-002 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-000-002 | FDA UDI | Class II | Active |
| KidneyVault | PRGNX-8008-010 | FDA UDI | Class II | Unknown |
| PancreasPak | SHRP-3003-002 | FDA UDI | Class II | Active |
| KidneyVault | PRGNX-8008-002 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-000-003 | FDA UDI | Class II | Active |
| LUNGguard | PRGNX-5005-001 | FDA UDI | Class II | Active |
| KidneyVault | PRGNX-8008-010 | FDA UDI | Class II | Active |
| BAROguard | 112 | FDA UDI | Class II | Unknown |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-002 | FDA UDI | Class II | Active |
| BAROguard | PRGNX-7007-001 | FDA UDI | Class II | Active |
| KidneyVault | PRGNX-8008-001 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001 | FDA UDI | Class II | Active |
| KidneyVault | PRGNX-8008-003 | FDA UDI | Class II | Active |
| Paragonix SherpaPak Cardiac Transport System | SHRP-1001-000-001 | FDA UDI | Class II | Active |
| LIVERguard | PRGNX-6006-002 | FDA UDI | N/A | Active |
| PancreasPak | SHRP-3003 | FDA UDI | Class II | Active |
| BAROguard | PRGNX-7007-003-001 | FDA UDI | Class II | Active |
| LIVERguard | PRGNX-6006-001 | FDA UDI | Class II | Active |
| BAROguard | PRGNX-7007-003 | FDA UDI | Class II | Active |
| SherpaPak Cardiac Transport System (CTS) | 360 | EUDAMED | Class IIa | Active |
| SherpaPak Cardiac Transport System (CTS) | 400 | EUDAMEDFDA UDI | Class IIa | Active |
| Sherpa Pak Kidney Transport System | K143054 | FDA 510(k) | Class II | Active |
| BAROguard Donor Lung Preservation System | K254305 | FDA 510(k) | Class II | Active |
| KIDNEYvault Portable Renal Perfusion System | K234060 | FDA 510(k) | Class II | Active |
| SherpaPak Pediatric Liver Transport System | K201048 | FDA 510(k) | Class II | Active |
| SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | K180194 | FDA 510(k) | Class II | Active |
| Paragonix SherpaPak Pancreas Transport System | K191440 | FDA 510(k) | Class II | Active |
| LIVERguard | 371 | EUDAMED | Class IIa | Active |
| BAROguard | 409 | EUDAMEDFDA UDI | Class IIa | Active |
| LUNGguard | 370 | EUDAMED | Class IIa | Active |
| LIVERguard | 411 | EUDAMED | Class IIa | Active |
| BAROguard | 10653 | EUDAMED | Class IIa | Active |
| PancreasPak Organ Preservation System | SHRP-3003-001 | EUDAMEDFDA UDI | Class IIa | Active |
| SherpaPak Cardiac Transport System (CTS) | 206 | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.