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

NewLife Intensity - M638AS09440 Catalog Number :

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

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity - M638AS0944U0 Catalog Number :

Device Description : Oxygen concentrator, 1-8 LPM with oxygen monitor, remanufactured

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

FreeStyle - M638AS09510 Catalog Number :

Device Description : Portable Oxygen Concentrator, 1 - 3 LPM Equivalent

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

FreeStyle - M638AS0951CU0 Catalog Number :

Device Description : Portable Oxygen Concentrator, 1-3 LPM, Re-manufactured, complete unit.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

FreeStyle - M638AS0951U0 Catalog Number :

Device Description : Portable oxygen concentrator, 1-3 LPM pulse dose delivery, remanufactured

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire 3 - M638AS09660 Catalog Number :

Device Description : Oxygen Concentrator, 1-3 LPM, base model

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire - M638AS09670 Catalog Number :

Device Description : Oxygen Concentrator, 1-3 LPM, with Oxygen Monitor option.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire 3 - M638AS0967U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-3 LPM, with Oxygen Monitor option, re-manufactured.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire 2 - M638AS09680 Catalog Number :

Device Description : Oxygen Concentrator, 1-2 LPM, with Oxygen Monitor option.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire - M638AS09810 Catalog Number :

Device Description : Oxygen concentrator 1-5 LPM, base model

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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