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Sign in to claim this brandCSA Medical
United States·US-MF-000026367
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 131, Hartwell Avenue, Lexington, Massachusetts, United States
- Website
- rejuvenair.com/
- —
- —
- [email protected]
- Phone
- +1-781-538-4720
- PRRC Contact
- Heather Nigro
- EUDAMED SRN
- US-MF-000026367
- FDA FEI Number
- 3010140265
- DUNS Number
- —
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| truFreeze | CD6-001 | FDA UDI | Class II | Unknown |
| truFreeze | CD6-001 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00183 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | CC3-01 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00181 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00180 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00181 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00177 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00177 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00184 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | CD6-001 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00183 | FDA UDI | Class II | Unknown |
| truFreeze | CD3-001 | FDA UDI | Class II | Unknown |
| truFreeze | 20-00184 | FDA UDI | Class II | Unknown |
| truFreeze System | K152668 | FDA 510(k) | Class II | Active |
| truFreeze System | K162695 | FDA 510(k) | Class II | Active |
| truFreeze System | K161557 | FDA 510(k) | Class II | Active |
| truFreeze System | K163244 | FDA 510(k) | Class II | Active |
| truFreeze System | K143625 | FDA 510(k) | Class II | Active |
| Trufreeze System, Trufreeze Spray Kit | K113021 | FDA 510(k) | Class II | Active |
| Vortex Radial Spray Catheter | K201183 | FDA 510(k) | Class II | Active |
| Cryospray Ablation System, Model Cc2-Nam | K072651 | FDA 510(k) | Class II | Active |
| truFreeze System | K171626 | FDA 510(k) | Class II | Active |
| Trufreeze System | K133258 | FDA 510(k) | Class II | Active |
| truFreeze System | K150920 | FDA 510(k) | Class II | Active |
| truFreeze Rapid AV Spray Kit | K171522 | FDA 510(k) | Class II | Active |
| Cryospray Ablation System, Model Cu 8407020500 | K070893 | FDA 510(k) | Class II | Active |
| truFreeze System | K172041 | FDA 510(k) | Class II | Active |
| RejuvenAir | 20-00190 | EUDAMED | Class IIb | Active |
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