FDA.reportPublic FDA data

510(k) K223606

Device
LifeShield? Infusion Safety Software Suite
Applicant
Icu Medical, Inc.
510(k) number
K223606
Product code
PHC
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-24
Date received
2022-12-02
Regulation
880.5725
Classification name
Infusion Safety Management Software
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pernell Abrantes
Address
600 N. Field Dr. Lake Forest IL US 60045 60045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc.2026-04-02
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K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc.2025-04-02
K230665Dose IQ Safety SoftwareBaxter Healthcare Corporation2024-03-29
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K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG2022-03-01
K182092BD Intelliport SystemBecton, Dickinson and Company2019-04-30
K141474BECTON DICKINSON INTELLIPORT SYSTEMBecton, Dickinson & CO2014-12-18
K141193MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0Smiths Medical Asd, Inc.2014-07-25