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

Mixer, Breathing Gases, Anesthesia Inhalation (BZR) (6) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (3) Cannula, Nasal, Oxygen (CAT) (1)

Premarket Exempt

No Yes

Clear

Adult Nasal Cannula for GI Source - 00709078622458 Catalog Number :

Device Description : Adult Nasal Cannula, Soft Tipped, with 14' KROT

Device Class : 1

Duns Number: 092673953

Premarket Exempt : No

Product Code : CAT

Prescription Use : Yes

Device Count : 1

AMBU Co2 Detector - 05707480101054 Catalog Number :

Device Description : Carbon Dioxide Detector

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

AMBU Co2 Detector-Pedi - 05707480101061 Catalog Number :

Device Description : Carbon Dioxide Detector Pediatric

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

AMBU Co2 Detector - 05707480101146 Catalog Number :

Device Description : Carbon Dioxide Detector w/ Adapter

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Hyperinflation (AMBU) - 05707480103119 Catalog Number :

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

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation (ABMU) - 05707480103126 Catalog Number :

Device Description : Hyperinflation Elbow, Manometer Dock, 7' O2 and Manometer

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation (AMBU) - 05707480103133 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 :

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation (AMBU) - 05707480103140 Catalog Number :

Device Description : Disposable Hyperinflation System, 1L Bag (Latex Free), 7' O2 and Manometer

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation (AMBU) - 05707480103157 Catalog Number :

Device Description : Disposable Hyperinflation System, 1L Bag (Latex Free), 7' O2 and Pressure Lines

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation (AMBU) - 05707480103164 Catalog Number :

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

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