Breethe, Inc.

Address:1500 Joh Ave,Halethorpe,MD,21227,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

Control, Pump Speed, Cardiopulmonary Bypass (DWA) (4) Oxygenator, Cardiopulmonary Bypass (DTZ) (2) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (1)

Premarket Exempt

Clear

OXY-1 System - 00860001797909 Catalog Number : OXY-1 System-US

Device Description : OXY-1 System

Device Class : 2

Duns Number: 079455574

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

OXY-1 System - 00860001797916 Catalog Number : OXY-1 PLU Disposable-US

Device Description : OXY-1 PLU Disposable

Device Class : 2

Duns Number: 079455574

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

OXY-1 System - 00860001797930 Catalog Number : 001-3300-011

Device Description : OXY-1-Console

Device Class : 2

Duns Number: 079455574

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

OXY-1 System - 00860001797947 Catalog Number : 001-0301-001

Device Description : OXY-1 Pump Driver

Device Class : 2

Duns Number: 079455574

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

OXY-1 System - 00860001797954 Catalog Number : 001-0901-003

Device Description : OXY-1 E-drive

Device Class : 2

Duns Number: 079455574

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

OXY-1 System - 10860001797920 Catalog Number : 001-0403-004

Device Description : OXY-1 Condensate Tray

Device Class :

Duns Number: 079455574

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 5

OXY-1 System - 10860001797968 Catalog Number : 001-3300-039

Device Description : Console Intake Filter, 5pk

Device Class : 2

Duns Number: 079455574

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 5

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