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 1 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users.

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 2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users.

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 5 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users.

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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