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) (5) Spirometer, Therapeutic (Incentive) (BWF) (5)

Premarket Exempt

Clear

MC 300® Reusable Nebulizer - 00762860055520 Catalog Number :

Device Description : MC 300® Reusable Nebulizer

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AeroEclipse® ONE Breath Actuated Nebulizer Disposable - 00762860055537 Catalog Number :

Device Description : AeroEclipse® ONE Breath Actuated Nebulizer Disposable

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MC 300* Nebulizer with Universal Tubing - 00762860055544 Catalog Number :

Device Description : MC 300* Nebulizer with Universal Tubing

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing - 00762860055575 Catalog Number : 10555794050

Device Description : MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System - 00762860105010 Catalog Number :

Device Description : AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

AEROBIKA OPEP Manometer - 00762860105027 Catalog Number :

Device Description : AEROBIKA OPEP Manometer

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

AEROBIKA OPEP with Manometer - 00762860105041 Catalog Number :

Device Description : AEROBIKA OPEP with Manometer

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

RespiConnect* Adapter - 00762860125018 Catalog Number : 11250194040

Device Description : RespiConnect* Adapter

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

VersaPAP™ Positive Airway Pressure Device - 00762860215016 Catalog Number :

Device Description : VersaPAP™ Positive Airway Pressure Device

Device Class : 2

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

VersaPAP® Positive Airway Pressure Device - 00762860215054 Catalog Number :

Device Description : VersaPAP® Positive Airway Pressure Device with Universal Tubing

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

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