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) (3)

Premarket Exempt

Clear

NewLife Intensity 10 - M638AS0991U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 LPM, Dual flow option with 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 - M638AS09940 Catalog Number :

Device Description : Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxy Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 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 10 - M638AS0994U0 Catalog Number :

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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