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Infusion Safety Management Software

FDA product code PHC · 8 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5725
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-04-30 – 2026-04-02

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.

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