INOGEN, INC.

Address:600 Shiloh Rd.,Plano,TX,75074,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

Generator, Oxygen, Portable (CAW) (10)

Premarket Exempt

Clear

Inogen One G2 Oxygen Concentrator - 00817131020018 Catalog Number : IO-200

Device Description : Inogen One G2 Oxygen Concentrator (10-04779-XX-XX)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Inogen One G2 Oxygen Concentrator - 00817131020025 Catalog Number : IO-200

Device Description : Inogen One G2 Oxygen Concentrator (10-04779-XX-XX)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Inogen One G3 Oxygen Concentrator - 00817131020032 Catalog Number : IO-300

Device Description : Inogen One G3 Oxygen Concentrator (10-03500-XX-XX)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Inogen One G3 Oxygen Concentrator - 00817131020049 Catalog Number : IO-300

Device Description : Inogen One G3 Oxygen Concentrator (10-03500-XX-XX)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Inogen One G3 Oxygen Concentrator - 00817131020056 Catalog Number : IO-300

Device Description : Inogen One G3 Oxygen Concentrator (10-06124-XX-XX)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Inogen One G3 Oxygen Concentrator - 00817131020063 Catalog Number : IO-300

Device Description : Inogen One G3 Oxygen Concentrator (10-06124-XX-XX)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

OxyGo - 00817131020070 Catalog Number : IO-300

Device Description : OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

OxyGo - 00817131020087 Catalog Number : IO-300

Device Description : OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

OxyGo - 00817131020094 Catalog Number : IO-300

Device Description : OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

OxyGo - 00817131020100 Catalog Number : IO-300

Device Description : OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)

Device Class : 2

Duns Number: 136729634

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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