BAXTER HEALTHCARE CORPORATION

Address:7511 114TH AVENUE NORTH,LARGO,FL,33773,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, i.V. Fluid transfer (LHI) (9) System/device, pharmacy compounding (NEP) (3) SYSTEM/DEVICE, PHARMACY COMPOUNDING (NEP) (1) Syringe, piston (FMF) (1)

Premarket Exempt

No Yes

Clear

REPEATER - 00085412476520 Catalog Number : H93821

Device Description : REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Luer Lock Ends

Device Class : 2

Duns Number: 005083209

Premarket Exempt : Yes

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

REPEATER - 00085412476544 Catalog Number : H93829

Device Description : REPEATER Pump Universal Spike, Sterile, Luer Lock

Device Class : 2

Duns Number: 005083209

Premarket Exempt : Yes

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412476827 Catalog Number : H93884

Device Description : Luer Lock-to-Bag Adapter

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

REPEATER - 00085412477008 Catalog Number : H938331

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

Device Class : 2

Duns Number: 005083209

Premarket Exempt : Yes

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412477183 Catalog Number : H938724

Device Description : EXACTAMIX 2400 Valve Set, 24-Port Valve Assembly

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412477206 Catalog Number : H938735

Device Description : Calibration Bag (1000mL)

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412477213 Catalog Number : H938737

Device Description : EXACTAMIX Empty EVA Bag

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412477220 Catalog Number : H938738

Device Description : EXACTAMIX Empty EVA Bag

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412477237 Catalog Number : H938739

Device Description : EXACTAMIX Empty EVA Bag

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412477244 Catalog Number : H938740

Device Description : EXACTAMIX Empty EVA Bag

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

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