Day

December 13, 2017
Company:ICU Medical IncDate of Enforcement Report 12/13/2017 Class lI: PRODUCT ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:(a) 16037-64-01; MedNet 6.1b) 16037-64-02; MedNet 6.1c) 16037-64-03; MedNet 6.1d) 16037-64-04; MedNet 6.21The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion...
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Company:GE Medical Systems Information Technologies, Inc.Date of Enforcement Report 12/13/2017 Class lI: PRODUCT CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier softwareThe PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care...
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Company:Roche Diabetes Care, Inc.Date of Enforcement Report 12/13/2017 Class lI: PRODUCT Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood...
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

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Location: Boston, MA, USA
Dates:  June 2-4, 2020

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