Identity
- Trade Name
- XVIVO PGM Disposable Sensors™ FDA UDI
- Generic Name
- Lung donor-organ preservation/evaluation system lung-interface set FDA UDI
- Device Name
- The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS™) to monitor the pH and dissolved pO2 gas in STEEN Solution™ during ex-vivo lung assessment. FDA UDI
- Model / Reference
- 19033 FDA UDI
- Description
- The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS™) to monitor the pH and dissolved pO2 gas in STEEN Solution™ during ex-vivo lung assessment. FDA UDI
Identifiers
- Catalog Number
- 19033 FDA UDI
- Primary DI / UDI-DI
- 07350069520111 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
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lung donor-organ preservation/evaluation system lung-interface set
XVIVO PGM Disposable Sensors™ 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 Organ Chamber™ — XVIVO PERFUSION, INC. · Class III
- XVIVO Lung Cannula Set™ — XVIVO PERFUSION, INC. · Class III
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 f61daf29-05e7-4c33-ba64-7779d2ab88e4 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 19, 2026