Carefusion Corporation

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

PTV - 00845873000005 Catalog Number :

Device Description : ASSY, PKG, ENVE, GRN, DISS, ENGLISH

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PTV - 00845873000029 Catalog Number :

Device Description : ASSY, PKG, REVEL, GRN, DISS, ENGLISH

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PTV - 00845873000043 Catalog Number :

Device Description : PTM DISPLAY ASSY, PKG, ENGLISH

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTV - 00845873000203 Catalog Number :

Device Description : ASSY, LTV1000, W/ ACCESS, ENGLISH

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTM II - 00845873000333 Catalog Number :

Device Description : Assy, Packaging LTM II

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTV - 00845873000364 Catalog Number :

Device Description : ASSY, LTV1200, W/ ACCESS, ENGLISH

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTV - 00845873000913 Catalog Number :

Device Description : MR CONDITIONAL LTV 1200 SYSTEM

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTV - 00845873001750 Catalog Number :

Device Description : ASSY, LTV1000, W/ACCESS, JAPANESE

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTV - 00845873001767 Catalog Number :

Device Description : ASSY, LTV1000, W/ ACCESS, NORWEGIAN

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

LTV - 00845873001774 Catalog Number :

Device Description : ASSY, LTV1000, W/ ACCESS, RUSSIAN

Device Class : 2

Duns Number: 830432451

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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