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) (7) Ventilator, Continuous, Facility Use (CBK) (3)

Premarket Exempt

Yes No

Clear

Tiara - 10190752101838 Catalog Number :

Device Description : SNAPP 2.0,SMALL NO HEADGEAR

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101845 Catalog Number :

Device Description : SNAPP 2.0,MEDIUM NO HEADGEAR

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101852 Catalog Number :

Device Description : SNAPP 2.0,LARGE NO HEADGEAR

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101869 Catalog Number :

Device Description : SNAPP 2.0,X-LARGE NO HEADGEAR

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101876 Catalog Number :

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

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101883 Catalog Number :

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

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101890 Catalog Number :

Device Description : ADV.FULL FACEMASK, MED W/4PT HG

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101913 Catalog Number :

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

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101920 Catalog Number :

Device Description : ADV FULL FACE MASK,LG W/4PT HG

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Tiara - 10190752101944 Catalog Number :

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

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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