WESTMED, INC.

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

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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) (9) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (1)

Premarket Exempt

No Yes

Clear

Hyperinflation AMBU - 05707480137602 Catalog Number :

Device Description : Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Ambu Hyper System - 05707480137626 Catalog Number :

Device Description : Hyperinflation System, 1L bag (not made with Latex), 7' O and Pressure lines, 40 Hyperinflation System, 1L bag (not made with Latex), 7' O and Pressure lines, 40cm H2O Pop-Valve

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation AMBU - 05707480137640 Catalog Number :

Device Description : Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 4 Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric 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

Hyperinflation - 05707480137664 Catalog Number :

Device Description : Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, I Hyperinflation System, 1L 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 - 05707480137688 Catalog Number :

Device Description : Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, P Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, Pediatric 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 - 05707480137701 Catalog Number :

Device Description : Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant Mask, 40 cm Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant 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

Hyperinflation AMBU - 05707480137725 Catalog Number :

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation AMBU - 05707480137749 Catalog Number :

Device Description : Disposable Hyperinflation System, 2L bag, 7' O2 and pressure lines, adult mask

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Hyperinflation AMBU - 05707480137763 Catalog Number :

Device Description : Disposable Hyperinflation System, 3L bag, 7' O2 and Pressure Lines, Adult mask

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

AnaPod - 10709078078009 Catalog Number :

Device Description : VOID Controller, Anesthesia Wick Circuit, 45 Deg C VOID

Device Class : 2

Duns Number: 092673953

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

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