Plum 360 Infusion System with Hospira MedNet Smart Card Plug N Play CE 3.0 Module for Plum A+ Infusion System Upgrade
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141789 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Plum 360 Infusion System is a pump, infusion device designed for the administration of parenteral, enteral, and epidural therapies, as well as whole blood and blood products. It delivers precise fluid infusion control in clinical settings such as general hospitals, supporting a range of intravenous, subcutaneous, and enteral applications. The system integrates advanced pumping technology to ensure accurate dosing and monitoring, enhancing patient safety and therapeutic outcomes.
This modular upgrade integrates with the Plum A+ Infusion System via a Smart Card Plug N Play CE 3.0 Module, enabling network connectivity through Hospira MedNet for enhanced data management and integration with hospital IT systems. Supplied as a reusable device, it requires sterile setup for patient use and adheres to FDA 510(k) clearance (K141789) under the General Hospital specialty classification. The system is classified as Class II and must be stored and handled according to manufacturer guidelines to maintain functionality and compliance.
Frequently asked questions
What is the Plum 360 Infusion System with MedNet upgrade used for?
The Plum 360 Infusion System with MedNet upgrade is designed for administering parenteral, enteral, and epidural therapies, as well as whole blood and blood products. It provides precise fluid infusion control for intravenous, subcutaneous, and enteral applications in clinical settings like general hospitals. The upgrade integrates with the Plum A+ system to enhance data management and hospital IT connectivity via Hospira MedNet.
How is the Plum 360 Infusion System supplied and prepared for use?
The Plum 360 Infusion System is supplied as a reusable device. Before patient use, it must be set up under sterile conditions to ensure safety and compliance with medical standards. The system requires proper handling and maintenance as outlined in the manufacturer’s guidelines to preserve functionality and sterility.
Is the Plum 360 Infusion System single-use or reusable?
The Plum 360 Infusion System is a reusable device. However, each use must adhere to sterile setup procedures to maintain patient safety and regulatory compliance. The system itself is not disposable but requires proper cleaning, maintenance, and storage between uses.
What regulatory approval does the Plum 360 Infusion System hold?
The Plum 360 Infusion System with MedNet upgrade holds FDA 510(k) clearance under the classification of General Hospital specialty, with the clearance number K141789. This indicates it has been deemed substantially equivalent to a predicate device and meets regulatory requirements for use in clinical settings.
How does the MedNet upgrade enhance the functionality of the Plum A+ system?
The MedNet upgrade enables network connectivity for the Plum A+ Infusion System through Hospira MedNet, allowing seamless integration with hospital IT systems. This integration facilitates enhanced data management, improved workflow efficiency, and better monitoring capabilities, ultimately supporting more precise and coordinated patient care.
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. Sources consulted: Plum 360™ Large-Volume Infusion Pump | ICU Medical, Plum 360 Infusion System With Hospira Mednet, Smart Card Plug N Play Ce ..., HOSPIRA PLUM 360 OPERATING MANUAL Pdf Download | ManualsLib, Hospira Plum 360 with MedNet System Quick Reference Card Software, PDF 5 510(k) Summary - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141789 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hospira, Inc.
Sources (1)
- FDA 510(k) K141789 24 fields · synced Oct 1, 2026