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Sign in to claim this brandXVIVO PERFUSION, INC.
US
Last updated September 17, 2026
What XVIVO PERFUSION, INC. makes
The company produces systems and consumables for preserving and evaluating donor lungs, including perfusion-based organ chambers, tubing sets, and perfusion solutions. Their portfolio also includes surgical irrigation tubing and disposable sensor kits designed for organ perfusion and monitoring. Examples include perfusion systems paired with Steen Solution perfusate, lung cannula sets, and single-use lung kits for ex vivo organ care.
These devices are regulated under FDA classifications, with some authorised as Class II and others as Class III. They appear in the FDA’s Pre-Market Approval (PMA) and Unique Device Identifier (UDI) registries. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 16080 Table Mountain Pkwy Ste 500, Golden, CO, 80403
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3009736925
- DUNS Number
- —
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PERFADEX Plus® | 19800 | FDA UDI | Class II | Unknown |
| STEEN Solution™ | 19004 | FDA UDI | Class III | Active |
| PERFADEX Plus (Click US) | 19850 | FDA UDI | Class II | Active |
| XVIVO Organ Chamber™ | 19020 | EUDAMEDFDA UDI | Class III | Active |
| XVIVO Perfusion System (XPS™) | 19030 | FDA UDI | Class III | Active |
| Silicon Tubing Set | 19005 | FDA UDI | Class II | Active |
| XVIVO Lung Disposables Kit | 19035 | FDA UDI | Class III | Unknown |
| PERFADEX Plus® | 19900 | FDA UDI | Class II | Unknown |
| XVIVO Click Adapter | 19024 | FDA UDI | Class II | Active |
| XVIVO Disposable Lung Kit | 19046 | FDA UDI | Class III | Active |
| PERFADEX® Plus | 19950 | FDA UDI | Class II | Active |
| Perfadex with THAM | 19018 | FDA UDI | Class II | Unknown |
| XVIVO PGM Disposable Sensors™ | 19033 | FDA UDI | Class III | Active |
| Perfadex with THAM | 19017 | FDA UDI | Class II | Unknown |
| XVIVO Click Adapter | 19125 | FDA UDI | Class II | Active |
| XVIVO Lung Cannula Set™ | 19022 | FDA UDI | Class III | Active |
| XVIVO Lung Cannula Set II™ | 19023 | FDA UDI | Class III | Unknown |
| Perfadex And Perfadex With Tham | K091989 | FDA 510(k) | Class II | Active |
| KIDNEY ASSIST-transport | K211333 | FDA 510(k) | Class II | Active |
| Perfadex Plus | K170826 | FDA 510(k) | Class II | Active |
| Xvivo Perfusion System (XPS) with Steen Solution Perfusate | P180014 | FDA PMA | Class III | Active |
Related Companies
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No authorised representatives on record.
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Xvivo Perfusion Ab Molndal Vastra Gotaland · SE FEI 3007710603