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Pharmguard Toolbox, Model G6000782

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042432

by Medex, Inc.

Identifiers

510(k) Number
K042432 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 Pharmguard Toolbox, Model G6000782 is a software-based configuration and data management tool for Medex infusion pumps. It functions as a vehicle to create, store, and securely upload user-defined drug libraries and infusion parameters to pumps. The device collects operational, infusion, and alarm history, as well as safety event logs from the pumps.

Clinicians or hospital staff use the tool in a general hospital setting. It is supplied as a reusable software tool and is not a sterile device. The device received FDA 510(k) clearance under K042432 and is classified as a Class II medical device under regulation number 880.5725 with product code FRN.

Frequently asked questions

What is the Pharmguard Toolbox Model G6000782 used for?

The Pharmguard Toolbox Model G6000782 is a software-based configuration and data management tool used to create, store, and securely upload user-defined drug libraries and infusion parameters to Medex infusion pumps. It also collects operational, infusion, alarm history, and safety event logs from the pumps, enabling clinicians to manage and review pump usage in a general hospital setting.

Is the Pharmguard Toolbox Model G6000782 a sterile or single-use device?

The Pharmguard Toolbox Model G6000782 is supplied as a reusable software tool and is not a sterile device. Since it is software-based and intended for repeated use in a hospital environment, it does not require sterilization and is designed for ongoing, multiple uses by clinicians or hospital staff.

What regulatory clearance does the Pharmguard Toolbox Model G6000782 have?

The Pharmguard Toolbox Model G6000782 received FDA 510(k) clearance under submission number K042432. It is classified as a Class II medical device under regulation number 880.5725 with product code FRN, indicating it was found substantially equivalent to a legally marketed predicate device.

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: PHARMGUARD TOOLBOX, MODEL G6000782 (K042432) — FDA 510 (k) | Innolitics, PHARMGUARD TOOLBOX, MODEL G6000782 by MEDEX, INC. | FDA 510 (k) Summary, PHARMGUARD TOOLBOX, MODEL G6000782 510(k) K042432 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medex, Inc.

Sources (1)

  • FDA 510(k) K042432 24 fields · synced Sep 26, 2026