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) (10)

Premarket Exempt

No Yes

Clear

Hyperinflation (AMBU) - 05707480103171 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) - 05707480103188 Catalog Number :

Device Description : Disposable Hyperinflation System, 1/2L 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) - 05707480103195 Catalog Number :

Device Description : Disposable Hyperinflation System, 1/2L 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) - 05707480103201 Catalog Number :

Device Description : Disposable Hyperinflation System, 2L 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) - 05707480103218 Catalog Number :

Device Description : Disposable Hyperinflation System, 3L 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 - 05707480137503 Catalog Number :

Device Description : Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-valve

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation AMBU - 05707480137527 Catalog Number :

Device Description : Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Ambu Hyper System - 05707480137541 Catalog Number :

Device Description : Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pres Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pressure Lines, Neonatal mask, H2O Pop-off valave

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Ambu Hyper System - 05707480137565 Catalog Number :

Device Description : Hyperinflation System, 1/2L bag (not made with Latex), 7' O2 and pressure lines, Hyperinflation System, 1/2L bag (not made with Latex), 7' O2 and pressure lines, Infant mask, 40 cm H2O pop-valve

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation AMBU - 05707480137589 Catalog Number :

Device Description : Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 4 Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O pop-off valve

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

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