Identity
- Trade Name
- BAROguard FDA UDI
- Generic Name
- General-purpose donor-organ preservation/transport system FDA UDI
- Device Name
- BAROguard Sterile Kit FDA UDI
- Model / Reference
- PRGNX-7007-003 FDA UDI
- Description
- BAROguard Sterile Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005470236 FDA UDI
- 510(k) Number
- K223874 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
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
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
BAROguard by Paragonix Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
Sources (1)
- FDA UDI 14067ce6-ebd5-4445-95af-c54b724931fe 34 fields · synced Jun 9, 2026