Identity
- Trade Name
- XVIVO Organ Chamber™ EUDAMEDFDA UDI
- Generic Name
- Lung donor-organ preservation/evaluation system lung-interface set FDA UDI
- Device Name
- XVIVO Organ Chamber™ EUDAMEDThe XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient. FDA UDI
- Model / Reference
- 19020 EUDAMEDFDA UDI
- Description
- The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient. FDA UDI
Identifiers
- Catalog Number
- 19020 FDA UDI
- Primary DI / UDI-DI
- 07350069520074 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350069520074 EUDAMED
- FDA Product Code
- PHO FDA UDI
- EMDN Code
- C0399 CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER EUDAMED
- GMDN Term
- Lung donor-organ preservation/evaluation system lung-interface set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Lung donor-organ preservation/evaluation system lung-interface set
XVIVO Organ Chamber™ by Xvivo Perfusion, Inc. — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Lung donor-organ preservation/evaluation system lung-interface set.
- XVIVO Disposable Lung Kit — XVIVO PERFUSION, INC. · Class III
- XVIVO PGM Disposable Sensors™ — XVIVO PERFUSION, INC. · Class III
- XVIVO Lung Cannula Set™ — XVIVO PERFUSION, INC. · Class III
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Xvivo Perfusion, Inc.
Sources (2)
- FDA UDI 0fd695a2-d991-4b00-97c0-96c317c35631 35 fields · synced Jun 20, 2026
- EUDAMED dc797baf-5c77-4908-bd4d-15b7963e776b 61 fields · synced Jun 18, 2026