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) (7) Syringe, piston (FMF) (2) CONTAINER, I.V. (KPE) (1) SYSTEM/DEVICE, PHARMACY COMPOUNDING (NEP) (1)

Premarket Exempt

Clear

EXACTAMIX - 00085412477466 Catalog Number : H938901

Device Description : EXACTAMIX Empty EVA Dual Chamber Container With Screw Connectors

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

TWOFER - 00085412478395 Catalog Number : H93816004

Device Description : TWOFER Huber-Tipped Needle

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

TWOFER - 00085412478401 Catalog Number : H93816045

Device Description : TWOFER Huber-Tipped Needle

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

TWOFER - 00085412478418 Catalog Number : H93819003

Device Description : TWOFER Huber-Tipped Needle

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

TWOFER - 00085412478425 Catalog Number : H93819035

Device Description : TWOFER Huber-Tipped Needle

Device Class :

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412480077 Catalog Number : H938711018

Device Description : EXACTAMIX Connector, Tube Set Calibration Extension

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

NA - 00085412480664 Catalog Number : H93813MPI

Device Description : Fluid Transfer Tube Set, Standard Volume, Oral, MPI

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

NA - 00085412481401 Catalog Number : H9389BTS

Device Description : Euclid Standard Oral Liquid, Transfer Tube Set

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412492001 Catalog Number : H938G792

Device Description : EXACTAMIX 1200 Valve Set, 12-Port Valve Assembly

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : NEP, LHI

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412492056 Catalog Number : H938G751

Device Description : EXACTAMIX Inlet, Vented, Micro-Volume Inlet

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

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