AIRWAYS DEVELOPMENT COMPANY LLC

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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

Attachment, Breathing, Positive End Expiratory Pressure (BYE) (4)

Premarket Exempt

Clear

WaterPAP - 00862146000302 Catalog Number :

Device Description : Positive Airway pressure device

Device Class : 2

Duns Number: 109509435

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WaterPAP PRO - 00862146000319 Catalog Number :

Device Class : 2

Duns Number: 109509435

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WaterPAP Starter Kit - 90862146000329 Catalog Number :

Device Description : WaterPAP Starter Kit consists of 4 WaterPAP canisters, 4 10mm Corrugated tubes, WaterPAP Starter Kit consists of 4 WaterPAP canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole clamp, Instructions for use

Device Class : 2

Duns Number: 109509435

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WaterPAP PRO Starter Kit - 90862146000336 Catalog Number :

Device Description : WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructions for use.

Device Class : 2

Duns Number: 109509435

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

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