CAIRE INC.

Address:2200 Airport Industrial Dr Ste 500,Ball Ground,GA,30107,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

Flowmeter, Calibration, Gas (BXY) (3) Unit, Liquid-Oxygen, Portable (BYJ) (2)

Premarket Exempt

No Yes

Clear

Companion 41 - M766B775930000 Catalog Number :

Device Description : Base Liquid Oxygen Respiratory Equipment, Top Fill, 6 LPM, 20 PSI

Device Class : 2

Duns Number: 807537683

Premarket Exempt : No

Product Code : BYJ

Prescription Use : Yes

Device Count : 1

SureFlow - M766FM06910 Catalog Number :

Device Description : 1 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters

Device Class : 1

Duns Number: 807537683

Premarket Exempt : Yes

Product Code : BXY

Prescription Use : Yes

Device Count : 1

SureFlow - M766FM06920 Catalog Number :

Device Description : 2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters

Device Class : 1

Duns Number: 807537683

Premarket Exempt : Yes

Product Code : BXY

Prescription Use : Yes

Device Count : 1

SureFlow - M766FM06950 Catalog Number :

Device Description : 5 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters

Device Class : 1

Duns Number: 807537683

Premarket Exempt : Yes

Product Code : BXY

Prescription Use : Yes

Device Count : 1

HELiOS 850 - M766H850EU0 Catalog Number :

Device Description : Portable Liquid Oxygen Respiratory Equipment, Top Fill, 6 LPM, 20 PSI

Device Class : 2

Duns Number: 807537683

Premarket Exempt : No

Product Code : BYJ

Prescription Use : Yes

Device Count : 1

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