FDA-Device2016-04-20Class I
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Dexcom Inc
Hazard
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Sold states
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
Affected count
41,925
Manufactured in
6340 Sequence Dr, N/A, San Diego, CA, United States
Products
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2016Don't want to check this manually?
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