BAXTER CORPORATION ENGLEWOOD

BAXTER CORPORATION ENGLEWOOD

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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, i.V. Fluid transfer (LHI) (4) Syringe, piston (FMF) (4) Set, administration, intravascular (FPA) (2)

Premarket Exempt

No

Clear

REPEATER - 00085412476513 Catalog Number : H93813

Device Description : REPEATER Pump Fluid Transfer Tube Set, Non-Sterile

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

NA - 00085412476551 Catalog Number : H93835

Device Description : Sterile 0.2 Micron Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMED - 00085412476575 Catalog Number : H93847

Device Description : Dispensing Pin

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 1

REPEATER - 00085412476599 Catalog Number : H93812

Device Description : REPEATER Pump Fluid Transfer Tube Set, Non-Vented Spike - Luer Lock

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

REPEATER - 00085412476681 Catalog Number : H93862

Device Description : REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Bifurcated Sets

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

REPEATER - 00085412476698 Catalog Number : H93863

Device Description : REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Trifurcated

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412476704 Catalog Number : H93865

Device Description : EXACTAMIX Connector, Tube Set Extension Piece

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412476711 Catalog Number : H93866

Device Description : EXACTAMIX Adapter, Bag Adapter, with Blunt Spike

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

REPEATER - 00085412476841 Catalog Number : H93887

Device Description : REPEATER Pump Extension Set, Male LL to Male LL

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

NA - 00085412476865 Catalog Number : H93891

Device Description : Vial Adapter 20mm - Luer Lock

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

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