Identity
- Trade Name
- XVIVO Perfusion System (XPS™) FDA UDI
- Generic Name
- Lung donor-organ preservation/evaluation system FDA UDI
- Device Name
- The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas-sessed for transplantation. FDA UDI
- Model / Reference
- 19030 FDA UDI
- Description
- The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas-sessed for transplantation. FDA UDI
Identifiers
- Catalog Number
- 19030 FDA UDI
- Primary DI / UDI-DI
- 07350069520104 FDA UDI
- FDA Product Code
- PHO FDA UDI
- GMDN Term
- Lung donor-organ preservation/evaluation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lung donor-organ preservation/evaluation system
XVIVO Perfusion System (XPS™) by Xvivo Perfusion, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Xvivo Perfusion, Inc.
Sources (1)
- FDA UDI d1d0ddbc-e0b5-46c3-8953-fcc925b39564 36 fields · synced Jun 20, 2026