CAREFUSION 303, INC.

Address:10020 PACIFIC MESA BLVD.,SAN DIEGO,CA,92121,US

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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

Set, administration, intravascular (FPA) (4) CABINET, TABLE AND TRAY, ANESTHESIA (BRY) (2) Pump, infusion (FRN) (1) Pump, infusion, pca (MEA) (1) SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS (MMH) (1) Set, i.V. Fluid transfer (LHI) (1)

Premarket Exempt

No Yes

Clear

MaxGuard - 10885403236006 Catalog Number : ME1048

Device Description : 12 IN NON-DEHP MINIBORE EXTENSION SET

Device Class :

Duns Number: 360624720

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

MaxGuard - 10885403236020 Catalog Number : ME1055

Device Description : 30-IN STANDARDBORE EXT SET

Device Class :

Duns Number: 360624720

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

MaxGuard - 10885403236334 Catalog Number : MFS102

Device Description : 100 IN 10 DROP ADMIN SET W/FLOW CON

Device Class :

Duns Number: 360624720

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

MaxGuard - 10885403236471 Catalog Number : MFS141

Device Description : EXT SET W/FLOW CNTRL,NDLELESS,Y-SITE 14

Device Class :

Duns Number: 360624720

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

SmartSite - 10885403284137 Catalog Number : MV0550

Device Description : SmartSite® VialShield Univ. Closed VAD

Device Class : 2

Duns Number: 360624720

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

Pyxis - 10885403421532 Catalog Number :

Device Description : Pyxis Transfusion Verification

Device Class : 2

Duns Number: 360624720

Premarket Exempt : No

Product Code : MMH

Prescription Use : No

Device Count : 1

Alaris - 10885403424267 Catalog Number : 8110

Device Description : Alaris Syringe Module

Device Class : 2

Duns Number: 360624720

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Pyxis - 10885403477829 Catalog Number : 338

Device Description : Pyxis Anesthesia System 4000

Device Class : 1

Duns Number: 360624720

Premarket Exempt : Yes

Product Code : BRY

Prescription Use : Yes

Device Count : 1

Pyxis - 10885403477836 Catalog Number : 327

Device Description : Pyxis Anesthesia System ES

Device Class : 1

Duns Number: 360624720

Premarket Exempt : Yes

Product Code : BRY

Prescription Use : Yes

Device Count : 1

Alaris - 10885403494291 Catalog Number : 8120

Device Description : Alaris PCA Module

Device Class : 2

Duns Number: 360624720

Premarket Exempt : No

Product Code : MEA

Prescription Use : Yes

Device Count : 1

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