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

Visioniare - M638AS0981U0 Catalog Number :

Device Description : Oxygen concentrator, 1-5 LPM, 115V/60Hz, base model, remanufactured

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire - M638AS09840 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM with Oxygen Monitor Option

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire - M638AS0984U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 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

VisonAire - M638AS0987070 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM, with Air Outlet option.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

VisionAire - M638AS0987100 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM, with Air Outlet, Oxygen Monitor options

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity 10 - M638AS09910 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 LPM, Dual flow option, Standard 1-10 LPM flow meters.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity 10 - M638AS0991000 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 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 10 - M638AS099100U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 LPM, Single flow, Re-manufactured.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Intensity 10 - M638AS0991010 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 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 10 - M638AS099101U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 LPM, Single flow, with Oxygen Monitor, Re-manufactured.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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