Dexcom, Inc.

Dexcom, Inc.

Address:232 South Dobson Road,Mesa,AZ,85202,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sensor, Glucose, Invasive (MDS) (9) Continuous Glucose Monitor Retrospective Data Analysis Software (PHV) (1)

Premarket Exempt

No Yes

Clear

Dexcom Clarity - 00038270000451 Catalog Number :

Device Description : Data Manager Software

Device Class : 1

Duns Number: 123160736

Premarket Exempt : No

Product Code : PHV

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile IOS App - 00386270000002 Catalog Number :

Device Description : G5 Mobile IOS App Stand Alone Software

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Platinum Sensor - 00386270000019 Catalog Number :

Device Description : Sensor Applicator Assembly

Device Class :

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Platinum Sensor US - 00386270000033 Catalog Number :

Device Description : Sensor Applicator Assembly Automation

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Global Transmitter - 00386270000040 Catalog Number :

Device Description : G4 Global Transmitter

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 SBT Transmitter - 00386270000125 Catalog Number :

Device Description : G4 SBT Transmitter

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Professional Receiver Shield Pack - 00386270000132 Catalog Number :

Device Description : Dexcom G4 Professional Receiver Shield Pack

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : No

Device Count : 1

Dexcom Studio - 00386270000149 Catalog Number :

Device Description : Dexcom Studio CD

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G5 Transmitter - 00386270000224 Catalog Number :

Device Description : G5 Transmitter

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Receiver - 00386270000231 Catalog Number :

Device Description : G5 Mobile Receiver

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

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