FDA-Device2016-04-20Class I
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). 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
19,586
Manufactured in
6340 Sequence Dr, N/A, San Diego, CA, United States
Products
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). 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-1338-2016Don't want to check this manually?
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