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) (4) Compressor, Air, Portable (BTI) (1)

Premarket Exempt

Clear

EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN - 62860105514020 Catalog Number : 10551494010

Device Description : EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 10

AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing - 62860105541026 Catalog Number : 10554194050

Device Description : AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 50

AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing - 62860105542023 Catalog Number : 10554294050

Device Description : AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 50

OMBRA Compressor Air Filters - 62860105544027 Catalog Number : 10554494001

Device Description : Compressor Air Filter Replacements to be used with OMBRA Compressor

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : BTI

Prescription Use : No

Device Count : 50

MC 300 Nebulizer with Mouthpiece - 62860105550028 Catalog Number : 10555094050

Device Description : MC 300 Nebulizer with Mouthpiece

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 50

MC 300*R Nebulizer with Mouthpiece - 62860105552022 Catalog Number : 10555294050

Device Description : MC 300* Reusable Nebulizer with Mouthpiece

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 50

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System - 62860110501022 Catalog Number : 11050194010

Device Description : AEROBIKA Oscillating Positive Expiratory Pressure Therapy System (package of 10)

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 10

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System - 62860110501046 Catalog Number : 11050194100

Device Description : AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 100

AEROBIKA OPEP Manometer - 62860110502029 Catalog Number : 11050294025

Device Description : AEROBIKA OPEP Manometer

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 25

AEROBIKA OPEP with Manometer - 62860110504023 Catalog Number : 11050494010

Device Description : AEROBIKA OPEP with Manometer (package of 10)

Device Class :

Duns Number: 203298203

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 10

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