4 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
FDA Enforcement
Class II
·Terminated·InfuTronix LLC·July 31, 2019
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
FDA Enforcement
Class II
·Ongoing·InfuTronix LLC·April 6, 2022
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
FDA Enforcement
Class I
·Ongoing·InfuTronix LLC·April 3, 2024
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
FDA Enforcement
Class I
·Ongoing·InfuTronix LLC·April 3, 2024