3 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
FDA Enforcement
Class III
·Terminated·Baxter Healthcare Corp.·September 5, 2012
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
FDA Enforcement
Class III
·Terminated·Baxter Healthcare Corp.·September 5, 2012
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
FDA Enforcement
Class III
·Terminated·Baxter Healthcare Corp.·November 25, 2015