| 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-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
|