BEUDAMED
    29 results · 68ms · Sources: EU EUDAMED, US FDA

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    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·November 23, 2016

    Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001

    FDA Enforcement
    Class II ·Ongoing·Roche Diabetes Care, Inc.·July 3, 2024

    Accu-Chek Connect Diabetes Management App

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·October 2, 2019

    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·February 21, 2018

    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·May 10, 2017

    AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·June 17, 2015

    Accu-Chek Connect Diabetes Management App

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·February 1, 2017

    AccuChek Spirit insulin infusion pump.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·June 17, 2015

    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·April 8, 2015

    Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·June 20, 2018

    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 glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·December 13, 2017

    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·June 20, 2018

    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·June 20, 2018

    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·October 9, 2019

    Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·October 9, 2019

    Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·January 8, 2020

    Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·February 12, 2020

    Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·January 8, 2020

    Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·February 12, 2020

    ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·February 12, 2020