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

SYSTEM/DEVICE, PHARMACY COMPOUNDING (NEP) (4) Set, i.V. Fluid transfer (LHI) (4) Syringe, piston (FMF) (4) Filter, infusion line (FPB) (2)

Premarket Exempt

Clear

EXACTAMIX - 00085412492117 Catalog Number : H938G724

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

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : NEP, LHI

Prescription Use : Yes

Device Count : 1

SUPOR - 05413765482656 Catalog Number : H93821002

Device Description : 25 mm 0.2 Micron Syringe Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

SUPOR - 05413765482663 Catalog Number : H93821012

Device Description : 25 mm 1.2 Micron Syringe Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

SUPOR - 05413765482670 Catalog Number : H93821050

Device Description : 25 mm 5 Micron Syringe Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

SUPOR - 05413765482700 Catalog Number : H93824640

Device Description : 32 mm 5 Micron Syringe Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

SUPOR - 05413765482717 Catalog Number : H93824642

Device Description : 32 mm 0.2 Micron Syringe Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

SUPOR - 05413765482731 Catalog Number : H93824648

Device Description : 32 mm 1.2 Micron Syringe Filter

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 05413765492013 Catalog Number : H938G173

Device Description : EXACTAMIX Inlet, Non-Vented, High-Volume Inlet

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 05413765492020 Catalog Number : H938G174

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

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 05413765492037 Catalog Number : H938G175

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

Device Class : 2

Duns Number: 078383477

Premarket Exempt : No

Product Code : LHI, NEP

Prescription Use : Yes

Device Count : 1

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