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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CSS7100 GUARDIAN REAL-TIME MONITOR; CSS7100k GUARDIAN REAL-TIME MONITOR; CSS72 Guardian REAL-Time Continuous Glucose Monitoring System; MMT-522 PARADIGM REAL-time Pump; MMT-522k PARADIGM REAL-time Pump; MMT-523 Paradigm REAL-Time Revel Insulin Pump; MMT-523k Paradigm REAL-Time Revel Insulin Pump; MMT-7002 SOF-SENSOR; MMT-7003 SOF-SENSOR; MMT-7102 CGMS System Gold; MMT-7203 CGMS Cable; MMT-722 PARADIGM REAL-time Pump; MMT-722k PARADIGM REAL-time Pump; MMT-723 Paradigm REAL-Time Revel Insulin Pump; MMT-723k Paradigm REAL-Time Revel Insulin Pump; MMT-7301 COM-STATION; MMT-7310 CGMS System Solutions Software; MMT-7311 SOLUTIONS; MMT-7315 GUARDIAN SOLUTIONS SOFTWARE; MMT-7319 Solutions Software For CGMS iPro CONTINUOUS GLUCOSE RECORDER; MMT-7333 CareLink Personal Therapy Management Software for Diabetes; MMT-7334 Medtronic CareLink; MMT-7335 CareLink Pro Therapy Management Software for Diabetes; MMT-7340 CareLink iPro; MMT-7500 Sen-serter; MMT-7703 MiniLink REAL-Time TRANSMITTER; MMT-7705 Charger; MMT-7706 Tester; MMT-7707 MiniLink┬┐ REAL-Time TRANSMITTER; MMT-7708 CGMS iPro Continuous Glucose Recorder; MMT-7709 CGMS iPro Recorder; MMT-7712 CGMS iPro Wand; MMT-7726 Watertight Tester; MMT-7741 iPro2; MMT-7742 iPro2 Dock; MMT-7744 iPro2 Cleaning Plugs; MMT-7745 iPro2; MMT-7747 Dock USB Cable; MMT-9100 MySentry System Kit; MMT-9101 MySentry Monitor; MMT-9102 MySentry Outpost
Classification Name: SENSOR, GLUCOSE, INVASIVE
Product Code: MDS
Device Class: 3
Registered Establishment Name: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Registered Establishment Number: 3004209178
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer
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