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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Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. The IntelliBridge solution is intended for use in professional healthcare facilities by trained healthcare professionals.
FDA Enforcement
Class III
·Terminated·Philips North America, LLC·June 19, 2019
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
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.
FDA Enforcement
Class III
·Terminated·Medtronic MiniMed Inc.·March 11, 2015