GAS CONTROL EQUIPMENT LIMITED

Address:100 Empress Park,Haydock St. Helens,GB

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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) (5)

Premarket Exempt

Clear

GCE - 05060456420000 Catalog Number :

Device Description : Zen-O Lite Clarity Portable Oxygen Concentrator

Device Class : 2

Duns Number: 296797616

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Arya - 05060456420017 Catalog Number :

Device Description : Zen-O lite Portable Oxygen Concentrator rebranded as Arya for First Class Medical

Device Class : 2

Duns Number: 296797616

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

GCE - 08592346004337 Catalog Number :

Device Description : Zen-O™ Portable Oxygen Concentrator

Device Class : 2

Duns Number: 296797616

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

GCE - 08592346658110 Catalog Number :

Device Description : Zen-O Lite Portable Oxygen Concentrator

Device Class : 2

Duns Number: 296797616

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

GCE - 08592346679832 Catalog Number :

Device Description : Zen-O™ Clarity Portable Oxygen Concentrator

Device Class : 2

Duns Number: 296797616

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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