Carefusion Corporation

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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

Ventilator, Continuous, Facility Use (CBK) (8) Ventilator, Non-Continuous (Respirator) (BZD) (2)

Premarket Exempt

Yes No

Clear

Infant Flow SiPAP - 70846446004795 Catalog Number : 777084-106

Device Description : INFANT FLOW, BONNETS, 3, LIGHT BLUE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 70846446004801 Catalog Number : 777084-103

Device Description : INFANT FLOW, BONNETS, 0, PINK

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 70846446004818 Catalog Number : 777084-104

Device Description : INFANT FLOW, BONNETS, 1, LIGHT BROWN

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 70846446004825 Catalog Number : 777084-105

Device Description : INFANT FLOW, BONNETS, 2, YELLOW

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow - 70846446005891 Catalog Number : 26404-001

Device Description : Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/10)

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Infant Flow - 70846446005907 Catalog Number : 26405-001

Device Description : Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/20)

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Vela - 70846446010130 Catalog Number : 09531D

Device Description : Circuit tubing, 18" smooth bore, pack of 10

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 10

Vela - 70846446033368 Catalog Number : 00423D

Device Description : 22 mm ID cuff adapter, pack of 10

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 10

AVEA - 70846446060395 Catalog Number :

Device Description : ESOPHAGEAL PRESSURE MONITORING TUBE SET, 8FR ADULT, BX 10

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 10

Vela - 70846446063785 Catalog Number : 09532D

Device Description : Circuit tubing, 18" smooth bore, pack of 10

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 10

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