Identity
- Trade Name
- XVIVO Lung Cannula Set II™ FDA UDI
- Generic Name
- Lung donor-organ preservation/evaluation system lung-interface set FDA UDI
- Device Name
- XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment. FDA UDI
- Model / Reference
- 19023 FDA UDI
- Description
- XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment. FDA UDI
Identifiers
- Catalog Number
- 19023 FDA UDI
- Primary DI / UDI-DI
- 07350069520500 FDA UDI
- PMA Number
- P180014 FDA UDI
- FDA Product Code
- PHO FDA UDI
- GMDN Term
- Lung donor-organ preservation/evaluation system lung-interface set FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
XVIVO Lung Cannula Set II™ by Xvivo Perfusion, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P180014 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xvivo Perfusion, Inc.
Sources (1)
- FDA UDI a12fe2eb-fa55-4cec-8153-1877b43ad203 37 fields · synced Jun 20, 2026