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PancreasPak Organ Preservation System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SHRP-3003-001
Identity
- Trade Name
- PancreasPak Organ Preservation System EUDAMEDPancreasPak FDA UDI
- Generic Name
- General-purpose donor-organ preservation/transport system FDA UDI
- Device Name
- SherpaPak Family of Devices EUDAMEDPancreasPak Shipper Base FDA UDI
- Model / Reference
- SHRP-3003-001 EUDAMEDFDA UDI
- Description
- PancreasPak Shipper Base FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005470038 EUDAMEDFDA UDI
- Basic UDI-DI
- 850005470SHRPF9L EUDAMED
- FDA Product Code
- KDN FDA UDI
- EMDN Code
- A0999 ORGAN PRESERVATION SOLUTIONS AND CONTAINERS - OTHER EUDAMED
- GMDN Term
- General-purpose donor-organ preservation/transport system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
PancreasPak Organ Preservation System by Paragonix Technologies, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 850005470SHRPF9L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
- EUDAMED SRN
- US-MF-000038585
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f39cb5c1-9580-42c6-b465-116d5c987cd4 61 fields · synced Jun 17, 2026
- FDA UDI ec8820a5-ec27-4daa-93b1-7c6f042370a4 34 fields · synced May 30, 2026