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, Non-Continuous (Respirator) (BZD) (8) Filter, Bacterial, Breathing-Circuit (CAH) (1) Ventilator, Continuous, Facility Use (CBK) (1)

Premarket Exempt

Yes No

Clear

Tiara - 10190752101951 Catalog Number :

Device Description : Advantage FFM, XL w/4-Pt-Hg

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101968 Catalog Number : TBF-100-10

Device Description : Filter, breathing -circuit

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101975 Catalog Number :

Device Description : FULL ADV.MASK,NON-VENTED,W/HDGR,XL

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101982 Catalog Number :

Device Description : BELLOWS BODY ASSEMBLY,SNAPP 2.0,SMALL

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101999 Catalog Number :

Device Description : BELLOWS BODY ASSEMBLY,SNAPP 2.0,MEDIUM

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752102002 Catalog Number :

Device Description : BELLOWS BODY ASSEMBLY,SNAPP 2.0,LARGE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752102019 Catalog Number :

Device Description : BELLOWS BODY ASSEMBLY,SNAPP 2.0,X-LARGE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752102026 Catalog Number :

Device Description : SNAPP 2.0 START-UP KIT

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752102033 Catalog Number :

Device Description : nCPAP Mask, w/ V.Swivel, Small

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752102040 Catalog Number :

Device Description : nCPAP Mask, w/ V.Swivel, Sm, w/Hg

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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