OXUS AMERICA, INC.

Address:2046 Brown Rd,Auburn Hills,MI,48326,US

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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

Oxus / GCE - 00867460000106 Catalog Number :

Device Description : Zen-O™ Portable Oxygen Concentrator

Device Class : 2

Duns Number: 962894098

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Oxus / GCE - 00867460000137 Catalog Number :

Device Description : Zen-O Lite Portable Oxygen Concentrator

Device Class : 2

Duns Number: 962894098

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Oxus / GCE - 00867460000144 Catalog Number :

Device Description : Zen-O™ Clarity Portable Oxygen Concentrator

Device Class : 2

Duns Number: 962894098

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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