Identity
- Trade Name
- BAROguard FDA UDI
- Generic Name
- General-purpose donor-organ preservation/transport system FDA UDI
- Device Name
- BAROguard SherpaCool Outer Box Contains: BAROguard SherpaCool Inner Box (00850005470229) FDA UDI
- Model / Reference
- 112 FDA UDI
- Description
- BAROguard SherpaCool Outer Box Contains: BAROguard SherpaCool Inner Box (00850005470229) FDA UDI
Identifiers
- Catalog Number
- PRGNX-7007-002 FDA UDI
- Primary DI / UDI-DI
- 10850005470226 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
- Not 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
BAROguard by Paragonix Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
Sources (1)
- FDA UDI 582cd0c6-078f-43dc-ba3c-9b3277befca1 36 fields · synced Jun 9, 2026