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) (10)

Premarket Exempt

No Yes

Clear

Infant Flow SiPAP - 50846446004579 Catalog Number : 777018

Device Description : INFANT FLOW LP, BONNET, 2, YELLOW

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004586 Catalog Number : 777020

Device Description : INFANT FLOW LP, BONNET, 3, LIGHT BLUE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004593 Catalog Number : 777000S

Device Description : INFANT FLOW LP, NASAL PRONGS, PINK

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004609 Catalog Number : 777000XL

Device Description : INFANT FLOW LP, NASAL PRONGS, CLEAR

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004616 Catalog Number : 7772020LP

Device Description : PACKAGE ASSEMBLY,INFANT FLOW,LP

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004623 Catalog Number : 777022

Device Description : INFANT FLOW LP, BONNET, 4, GOLD

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004630 Catalog Number : 777000M

Device Description : INFANT FLOW LP, NASAL PRONGS, BLUE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004647 Catalog Number : 777012

Device Description : INFANT FLOW LP, BONNET, 00, GRAY

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004654 Catalog Number : 777026

Device Description : INFANT FLOW LP, BONNET, 6, LIGHT BURGUNDY

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004661 Catalog Number : 777000L

Device Description : INFANT FLOW LP, NASAL PRONGS, PURPLE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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