Product Code: MDS


Products Classified as MDS

705Sensor, Glucose, Invasive

Total Product Life Cycle (TPLC) Devices

705Sensor, Glucose, Invasive

FDA Consensus Standards

Sensor, Glucose, Invasive [35909]21 CFR Unclassified 🔎
Sensor, Glucose, Invasive [35812]21 CFR Unclassified 🔎
Sensor, Glucose, Invasive [27798]21 CFR Unclassified 🔎
Sensor, Glucose, Invasive [32928]21 CFR Unclassified 🔎
Sensor, Glucose, Invasive [35892]21 CFR Unclassified 🔎

Pre-market Approvals for MDS

P120010ENLITE SENSORMEDTRONIC Inc.
P130007ANIMAS VIBE SYSTEMANIMAS CORP.
P140015TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEMTandem Diabetes Care, Inc.
P980022Paradigm real time Insulin Pump / Paradigm Real time revel Insulin PumpMEDTRONIC MINIMED
P150021FreeStyle Libre Pro Flash Glucose Monitoring SystemAbbott Diabetes Care Inc.
P120005Dexcom G5 Mobile Continuous Glucose Monitoring SystemDEXCOM, INC.
P150019Real-Time REVEL SystemMEDTRONIC MINIMED
P150029iPro2 SystemMEDTRONIC MINIMED
P160007Guardian Connect TransmitterMEDTRONIC MINIMED

Global Unique Device Identification Database

00386270000279Sensor, Glucose, Invasive
00386270000262Sensor, Glucose, Invasive
00386270000231Sensor, Glucose, Invasive
00386270000224Sensor, Glucose, Invasive
00386270000149Sensor, Glucose, Invasive
10386270000139Sensor, Glucose, Invasive
00386270000125Sensor, Glucose, Invasive
00386270000040Sensor, Glucose, Invasive
00386270000033Sensor, Glucose, Invasive
00386270000019Sensor, Glucose, Invasive
00386270000002Sensor, Glucose, Invasive
30357599716876Sensor, glucose, invasive
30357599715626Sensor, glucose, invasive
30357599715619Sensor, glucose, invasive
57599-0715-55Sensor, glucose, invasive

Maude Adverse Events

DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM, INC.2020-03-30
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SDEXCOM, INC.2020-03-30
DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM, INC.2020-03-30
NICONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-30
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-30
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-30
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-29
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-25
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-25
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-25
FREESTYLE LIBRE 14 DAY GLUCOSE SENSORABBOTT DIABETES CARE INC.2020-03-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-24
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-23
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-19
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-18
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-18
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-17
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-16
NICONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-14
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-13
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-13
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-13
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-13
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-13
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-12
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-12
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-12
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-11
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-11
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-11
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-11
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-10
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-10
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-10
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-09
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-09
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-09
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-09
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-09
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-06
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-06
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-06
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-05
CONTINUOUS GLUCOSE MONITORDEXCOM, INC.2020-03-05
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-05
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMDEXCOM, INC.2020-03-05
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