AIRSEP CORPORATION

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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

FreeStyle 5 - M638AS07710 Catalog Number :

Device Description : Portable Oxygen Concentrator, 1-5 LPM equivalent

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

FreeStyle 5 - M638AS0771CU0 Catalog Number :

Device Description : Portable Oxygen Concentrator, 1-5 LPM, Re-manufactured, complete unit.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

FREESTYLE 5 - M638AS0771U0 Catalog Number :

Device Description : PORTABLE OXYGEN CONCENTRATOR, 1-5 LPM, PULSE DOSE, REMANUFACTURED

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Focus - M638AS07810 Catalog Number :

Device Description : Portable Oxygen Concentrator, 2 LPM equivalent

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Focus - M638AS0781CU0 Catalog Number :

Device Description : Portable Oxygen Concentrator, 2 LPM, Re-manufactured, complete unit

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Focus - M638AS0781U0 Catalog Number :

Device Description : Portable oxygen concentrator, 2 lpm pulse dose flow, remanufactured

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity - M638AS09410 Catalog Number :

Device Description : Oxygen Concentrator, 1-8 LPM, Dual flow option with standard 1-8 LPM flow meters.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity - M638AS0941000 Catalog Number :

Device Description : Oxygen Concentrator, 1-8 LPM, Single Flow Meter, Base model

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity - M638AS0941010 Catalog Number :

Device Description : Oxygen Concentrator, 1-8 LPM, Single Flow Meter, with Oxygen Monitor Option

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity - M638AS0941U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-8 LPM, Dual flow option with standard 1-8 LPM flow meters Oxygen Concentrator, 1-8 LPM, Dual flow option with standard 1-8 LPM flow meters, Re-manufactured.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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