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) (6) Warmer, thermal, infusion fluid (LGZ) (2) Filter, bacterial, breathing-circuit (CAH) (1) NEBULIZER (DIRECT PATIENT INTERFACE) (CAF) (1)

Premarket Exempt

Yes No

Clear

Infant Flow SiPAP - 50846446004678 Catalog Number : 777024

Device Description : INFANT FLOW LP, BONNET, 5, GREEN

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004685 Catalog Number : 777010

Device Description : INFANT FLOW LP, BONNET, 000, WHITE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004692 Catalog Number : 777028

Device Description : INFANT FLOW LP, BONNET, 7, ORANGE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446006153 Catalog Number : 7772000LP

Device Description : PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

AirLife - 50885403199132 Catalog Number : 2M8021

Device Description : Airlife™ Nebulizer Heater

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Vital Signs - 50885403293465 Catalog Number : 5108PE

Device Description : Vital Signs&#8482 Fresh Gas Elbow

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1500

enFlow - 50885403296879 Catalog Number : 980305VS

Device Description : enFlow&#8482 Warmer Holder

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 20

enFlow - 50885403296886 Catalog Number : 980309VS-20

Device Description : enFlow&#8482 Warmer Cord Clip

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 20

Vela - 70846446001268 Catalog Number : 16605

Device Description : Ped/Adult Airway Adapter

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 10

AVEA - 70846446001275 Catalog Number : 16606

Device Description : Neonatal/Pediatric Airway Adapter/ Single Patient Use

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 10

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