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, Non-Adjunctive (PQF) (5) Integrated Continuous Glucose Monitoring System, Factory Calibrated (QBJ) (3) Sensor, Glucose, Invasive (MDS) (2)

Premarket Exempt

No Yes

Clear

Dexcom G6 Sensor Applicator Assembly - 00386270000255 Catalog Number :

Device Description : G6 Sensor Applicator Assembly

Device Class :

Duns Number: 123160736

Premarket Exempt : No

Product Code : QBJ

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Receiver - 00386270000262 Catalog Number :

Device Description : G5 Mobile Receiver Adult Pink

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Receiver - 00386270000279 Catalog Number :

Device Description : G5 Mobile Receiver Adult Blue

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Android App - 00386270000293 Catalog Number :

Device Description : G5 Mobile Android App Stand Alone Software

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

Dexcom Receiver - 00386270000323 Catalog Number :

Device Description : Dexcom Receiver

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

Dexcom G6 Transmitter - 00386270000385 Catalog Number :

Device Description : G6 Transmitter

Device Class :

Duns Number: 123160736

Premarket Exempt : No

Product Code : QBJ

Prescription Use : Yes

Device Count : 1

Dexcom G6 Receiver - 00386270000583 Catalog Number :

Device Description : G6 Receiver

Device Class :

Duns Number: 123160736

Premarket Exempt : No

Product Code : QBJ

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Receiver Kit (Medicare) - 00386270000606 Catalog Number :

Device Description : G5 Mobile Receiver Kit (Medicare)

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Replacement Receiver Kit (Medicare) - 00386270000613 Catalog Number :

Device Description : G5 Mobile Replacement Receiver Kit (Medicare)

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

Dexcom G5 Mobile Transmitter Kit (Medicare) - 00386270000620 Catalog Number :

Device Description : G5 Mobile Transmitter Kit (Medicare)

Device Class : 3

Duns Number: 123160736

Premarket Exempt : No

Product Code : PQF

Prescription Use : Yes

Device Count : 1

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