Identity
- Trade Name
- Paragonix SherpaPak Cardiac Transport System FDA UDI
- Generic Name
- General-purpose donor-organ preservation/transport system FDA UDI
- Device Name
- Paragonix SherpaPak Cardiac Transport System Canister Ships with 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1) FDA UDI
- Model / Reference
- SHRP-1001 FDA UDI
- Description
- Paragonix SherpaPak Cardiac Transport System Canister Ships with 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869582000347 FDA UDI
- FDA Product Code
- MSB 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
Paragonix SherpaPak Cardiac Transport System by Paragonix Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 4703ae4f-3944-4685-8a01-9fb4bbac5680 34 fields · synced Jun 9, 2026