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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Dexcom ONE Continuous Glucose Monitoring System; Dexcom ONE+ Continuous Glucose Monitoring System
Classification Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Product Code: QBJ
Device Class: 2
Regulation Number: 862.1355
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Plexus Electronica S. de R.L. de C.V..
Registered Establishment Number: 3011120183
Owner/Operator: PLEXUS CORP.
Owner/Operator Number: 3019588
Establishment Operations: Contract Manufacturer
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