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

NEBULIZER (DIRECT PATIENT INTERFACE) (CAF) (5) Ventilator, Continuous, Facility Use (CBK) (5)

Premarket Exempt

Yes No

Clear

AirLife - 20885403164832 Catalog Number : 5251

Device Description : Airlife™ Modudose™ 0.9% Sodium Chloride Solution, USP, 3 ml

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

AirLife - 20885403164849 Catalog Number : 5257

Device Description : Airlife™ Modudose™ 0.9% Sodium Chloride Solution, USP, 5 ml

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

AirLife - 20885403164870 Catalog Number : AL7025

Device Description : Airlife™ Modudose™ Sterile Water for Inhalation, USP, 5 ml

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

AirLife - 20885403167260 Catalog Number : AL7455

Device Description : Airlife™ Modudose™ 0.45% Sodium Chloride Solution for Inhalation, USP, 5 ml

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

AirLife - 20885403230186 Catalog Number : AL7023

Device Description : Airlife™ Modudose™ Sterile Water for Inhalation, USP, 3 ml

Device Class :

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

Infant Flow SiPAP - 50846446004524 Catalog Number : 7772011

Device Description : PACKAGE ASSEMBLY,GENERATOR KIT W_RT132 CIRCUITS

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004531 Catalog Number : 777000XS

Device Description : INFANT FLOW LP, NASAL PRONGS, GREEN

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004548 Catalog Number : 7772010

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004555 Catalog Number : 777016

Device Description : INFANT FLOW LP, BONNET, 1, LIGHT BROWN

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Infant Flow SiPAP - 50846446004562 Catalog Number : 777014

Device Description : INFANT FLOW LP, BONNET, 0, PINK

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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