Airway Company, The

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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

Tube Tracheostomy And Tube Cuff (JOH) (2) Condenser, Heat And Moisture (Artificial Nose) (BYD) (1) Tubing, Pressure And Accessories (BYX) (1)

Premarket Exempt

No Yes

Clear

Shikani Speaking Valve - 00866035000305 Catalog Number :

Device Class : 2

Duns Number: 063502758

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

Shikani Speaking Valve - 00866035000312 Catalog Number :

Device Class : 2

Duns Number: 063502758

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

Shikani HME - 00866035000343 Catalog Number :

Device Class :

Duns Number: 063502758

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 5

Shikani HME Oxygen Tube - 00866035000350 Catalog Number :

Device Class : 1

Duns Number: 063502758

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

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