Trudell Medical International

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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

Nebulizer (Direct Patient Interface) (CAF) (9) Compressor, Air, Portable (BTI) (1)

Premarket Exempt

Clear

AEROTRACH PLUS Anti-Static Valved Holding Chamber - 00762860015050 Catalog Number :

Device Description : AEROTRACH PLUS Anti-Static Valved Holding Chamber

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN - 00762860050303 Catalog Number :

Device Description : EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

AEROECLIPSE II Breath Actuated Nebulizer Disposable - 00762860055018 Catalog Number :

Device Description : AEROECLIPSE II Breath Actuated Nebulizer Disposable

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter - 00762860055056 Catalog Number :

Device Description : AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable - 00762860055063 Catalog Number :

Device Description : Elbow Adapter for AEROECLIPSE II Breath Actuated Nebulizer Disposable

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OMBRA 120V Table Top Compressor System - 00762860055100 Catalog Number :

Device Description : OMBRA Table Top Compressor System (120V)

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

AEROECLIPSE XL Reusable Breath Actuated Nebulizer - 00762860055131 Catalog Number :

Device Description : AEROECLIPSE XL Reusable Breath Actuated Nebulizer

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing - 00762860055414 Catalog Number :

Device Description : AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing - 00762860055421 Catalog Number :

Device Description : AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MC 300 Nebulizer with Mouthpiece - 00762860055506 Catalog Number :

Device Description : MC 300 Nebulizer with Mouthpiece

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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