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U.S. Department of Health and Human Services

Product Classification

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Device infusion safety management software
Regulation Description Infusion pump.
Definition Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.
Physical State The device is a software application(s), which may be implemented as part of an infusion pump and may also be implemented onto a hospital information system for use with an infusion pump system.
Technical Method Infusion safety management software may include one or more software applications that enforce safety control mechanisms through wireless or wired communication between the hospital information system, the infusion pump, and the healthcare provider.
Target Area Target area is according to the approved drug or biologic product labeling.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePHC
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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