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Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042980

by Hospira, Inc.

Identifiers

510(k) Number
K042980 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 Hospira Gemstar Infusion Pump System with Hospira Gemstar Connect Software is an infusion pump system intended for intravenous, arterial, subcutaneous, short-term epidural infusion, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. It is designed for use by healthcare professionals, caregivers, and patients in general hospital settings.

The system is supplied as a reusable infusion pump system with associated software. It is regulated under FDA 510(k) clearance (K042980) and classified as a Class II medical device under regulation number 880.5725. The device is manufactured by Hospira, Inc. and is intended for use in general hospital environments.

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: HOSPIRA GEMSTAR SERIES SYSTEM OPERATING MANUAL Pdf Download, Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software ..., Hospira Gemstar - Series Infusion Pump | PDF - Scribd

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hospira, Inc.

Sources (1)

  • FDA 510(k) K042980 24 fields · synced Sep 28, 2026