AIRSEP CORPORATION

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

No

Clear

NewLife Elite - M638AS00510 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

NewLife Elite - M638AS005100 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 Elite - M638AS0051U0 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM, base model, Re-manufactured.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Elite - M638AS00540 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

NewLife Elite - M638AS0054U0 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

NewLife Elite - M638AS00570 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

NewLife Elite - M638AS005810 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM, with Oxy Silent option.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Elite - M638AS005840 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM, with Oxy Silent, Oxygen Monitor options

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Elite - M638AS005870 Catalog Number :

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

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

NewLife Elite - M638AS005900 Catalog Number :

Device Description : Oxygen Concentrator, 1-5 LPM, with Air Outlet, Oxygen Monitor, and Oxy Silent options.

Device Class : 2

Duns Number: 834499415

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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