Identity
- Trade Name
- LIVERguard FDA UDI
- Generic Name
- General-purpose donor-organ preservation/transport system FDA UDI
- Device Name
- Paragonix LIVERguard Shipper Base FDA UDI
- Model / Reference
- PRGNX-6006-001 FDA UDI
- Description
- Paragonix LIVERguard Shipper Base FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005470304 FDA UDI
- FDA Product Code
- KDN FDA UDI
- GMDN Term
- General-purpose donor-organ preservation/transport system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose donor-organ preservation/transport system
LIVERguard by Paragonix Technologies, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose donor-organ preservation/transport system.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- X°Port Lung Preservation System — Traferox Technologies, Inc. · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- KidneyVault — Paragonix Technologies, Inc. · Class II
- Paragonix SherpaPak Cardiac Transport System — Paragonix Technologies, Inc. · Class II
- PancreasPak — Paragonix Technologies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
Sources (2)
- FDA UDI 43845699-ca5e-4777-aed4-8a499e2fe8d8 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026