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) (5) Integrated Continuous Glucose Monitoring System, Factory Calibrated (QBJ) (2) Sensor, Glucose, Invasive, Non-Adjunctive (PQF) (2) Continuous Glucose Monitor Retrospective Data Analysis Software (PHV) (1)

Premarket Exempt

No Yes

Clear

Dexcom API - 00386270000668 Catalog Number :

Device Description : Public API that allows access by authorized third parties to select Dexcom data

Device Class : 1

Duns Number: 123160736

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : Yes

Device Count : 1

Dexcom G6 iOS - 00386270000804 Catalog Number :

Device Description : G6 iOS

Device Class : 2

Duns Number: 123160736

Premarket Exempt : No

Product Code : QBJ

Prescription Use : No

Device Count : 1

Dexcom G6 Android - 00386270000811 Catalog Number :

Device Description : G6 Android

Device Class : 2

Duns Number: 123160736

Premarket Exempt : No

Product Code : QBJ

Prescription Use : No

Device Count : 1

Dexcom Replacement Receiver Kit (Medicare) - 00386270000842 Catalog Number :

Device Description : Replacement Receiver Kit (Medicare)

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

Dexcom Receiver Kit (Medicare) - 00386270000859 Catalog Number :

Device Description : Dexcom Receiver Kit (Medicare)

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

Dexcom G4 Platinum Sensor Kit 1PK US - 10386270000016 Catalog Number :

Device Description : Sensor Kit 1 Pack US

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Platinum Transmitter Kit US - 10386270000047 Catalog Number :

Device Description : Transmitter Kit US (9438-05 31OCT2014)

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : No

Device Count : 1

Dexcom G4 Platinum (Pedicatric) Receiver Kit - 10386270000078 Catalog Number :

Device Description : G4 Platinum (Pediatric) Receiver Kit Black

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Platinum Receiver Kit (Retail) - 10386270000085 Catalog Number :

Device Description : G4 Platinum Receiver Kit (Retail) Adult Pink

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G4 Platinum Receiver - 10386270000092 Catalog Number :

Device Description : G4 Platinum Receiver Kit Adult Blue

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

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