WESTMED, INC.

Address:5580 S NOGALES HWY,TUCSON,AZ,85706,US

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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) Mixer, Breathing Gases, Anesthesia Inhalation (BZR) (1)

Premarket Exempt

No Yes

Clear

Hyperinflation (AMBU) - 00612649210094 Catalog Number :

Device Description : Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Line Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Heart® Continuous Nebulizer - 00709078000058 Catalog Number :

Device Description : Heart® Continuous Nebulizer

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Continuous Nebulizer Adult Kit,10cc Syringe - 00709078000065 Catalog Number :

Device Description : Heart® Continuous Nebulizer Adult Kit,10cc Syringe

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart®Direct Connect, Continuous Nebulizer, Pediatric Kit - 00709078000072 Catalog Number :

Device Description : Heart®Direct Connect, Continuous Nebulizer, Pediatric Kit

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Continuous Nebulizer, Pediatric Kit - 00709078000089 Catalog Number :

Device Description : Heart® Continuous Nebulizer, Pediatric Kit

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Continuous Nebulizer Holder - 00709078000096 Catalog Number :

Device Description : Heart® Continuous Nebulizer Holder

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Direct Connect Continuous Nebulizer - 00709078000102 Catalog Number :

Device Description : Heart® Direct Connect Continuous Nebulizer

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Direct Connect Continuous Nebulizer,Adult Kit - 00709078000119 Catalog Number :

Device Description : Heart® Direct Connect Continuous Nebulizer,Adult Kit

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Direct Connect Cont.Nebulizer,Ped. SuperSpike,3cc Sy - 00709078000126 Catalog Number :

Device Description : Heart® Direct Connect Cont.Nebulizer,Ped. SuperSpike,3cc Sy

Device Class :

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Heart® Direct Connect Cont.Nebulizer, Ped.Super Spike Mask - 00709078000133 Catalog Number :

Device Description : Heart® Direct Connect Cont.Nebulizer, Ped.Super Spike Mask

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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