SherpaPak Cardiac Transport System (CTS) 206
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- SherpaPak Cardiac Transport System (CTS) EUDAMED
- Device Name
- SherpaPak Family of Devices EUDAMED
- Model / Reference
- 206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00869582000309 EUDAMED
- Basic UDI-DI
- 850005470SHRPF9L EUDAMED
- EMDN Code
- A0999 ORGAN PRESERVATION SOLUTIONS AND CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The SherpaPak Cardiac Transport System (CTS) is a sterile, active medical device classified as a Class IIa transport system for cardiac organs. It is designed to maintain organ viability during transport by providing controlled temperature, humidity, and oxygenation, ensuring safe and effective preservation of donor hearts for transplantation.
The CTS is supplied as a single-use, non-reusable device with a unique reference code (206) and is authorized under FDA 510K and MDR regulations. It is intended for use in clinical settings such as operating rooms, transplant centers, and emergency transport scenarios. Storage and handling must comply with sterile field protocols, and its UDI (850005470SHRPF9L) ensures traceability and regulatory compliance.
Frequently asked questions
What clinical settings is the SherpaPak Cardiac Transport System designed for use in, and why is this important?
The SherpaPak Cardiac Transport System (CTS) is designed for use in clinical settings such as operating rooms, transplant centers, and emergency transport scenarios. This is important because it ensures that donor hearts can be safely and effectively preserved during transport between these critical locations, minimizing risks to organ viability and patient outcomes.
Is the SherpaPak Cardiac Transport System reusable, and if not, what does this mean for its handling and cost?
No, the SherpaPak Cardiac Transport System is a single-use, non-reusable device. This means each unit is intended for one-time use only, requiring strict adherence to sterile field protocols during handling and disposal. While this ensures sterility and reduces infection risks, it also implies higher operational costs due to the need for frequent replacements.
How does the UDI (Unique Device Identifier) for the SherpaPak Cardiac Transport System support regulatory compliance and traceability?
The UDI (850005470SHRPF9L) assigned to the SherpaPak Cardiac Transport System enables full traceability and regulatory compliance by providing a unique identifier for each device. This allows healthcare providers and regulatory bodies to track the device’s origin, batch, and expiration date, ensuring proper inventory management, recall coordination, and adherence to FDA 510K and MDR requirements.
Why is the SherpaPak Cardiac Transport System classified as sterile, and what does this mean for its storage and handling?
The SherpaPak Cardiac Transport System is classified as sterile to ensure that the device does not introduce contaminants during organ transport, which is critical for preserving the viability of donor hearts. This means it must be stored and handled under sterile field protocols to maintain its integrity and prevent cross-contamination, reducing the risk of infection or complications during transplantation.
What does the active medical device classification of the SherpaPak Cardiac Transport System imply about its functionality and operational requirements?
The SherpaPak Cardiac Transport System is classified as an active medical device, meaning it relies on an external power source or internal mechanisms (such as temperature control, humidity regulation, and oxygenation) to function. This classification implies that it requires proper calibration, maintenance, and operational checks to ensure it performs as intended—maintaining optimal conditions for organ preservation during transport.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133694 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K182735 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K123326 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K133432 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K143074 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 850005470SHRPF9L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
- EUDAMED SRN
- US-MF-000038585
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 615bd8a1-81c3-4612-9601-1ef8fb14d439 61 fields · synced Sep 18, 2026
- FDA 510(k) K133694 1 fields · synced May 18, 2026