BAXTER INTERNATIONAL INC.

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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) (7) CONTAINER, I.V. (KPE) (2) Set, blood transfusion (BRZ) (1)

Premarket Exempt

No Yes

Clear

INTERLINK - 00085412002408 Catalog Number : 2C6714

Device Description : Y-Type Blood/Solution Set with Large Standard Blood Filter, 170 to 260 Micron Fi Y-Type Blood/Solution Set with Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

INTERLINK/CONTROL-A-FLO - 00085412002422 Catalog Number : 2C6891

Device Description : Extension Set with CONTROL-A-FLO Regulator, Injection Site, Male Luer Lock Adapt Extension Set with CONTROL-A-FLO Regulator, Injection Site, Male Luer Lock Adapter with Retractable Collar

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412002576 Catalog Number : 2C7451

Device Description : Secondary Medication Set, Hanger, Lever Lock cannula, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK/DUO-VENT - 00085412002583 Catalog Number : 2C7452

Device Description : Secondary Medication Set with DUO-VENT Spike, Hanger, Lever Lock Cannula, Male L Secondary Medication Set with DUO-VENT Spike, Hanger, Lever Lock Cannula, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

DUO-VENT - 00085412002750 Catalog Number : 2C7552

Device Description : Nitroglycerin Set with DUO-VENT Spike, PVC Tubing Segment, Injection Site, Male Nitroglycerin Set with DUO-VENT Spike, PVC Tubing Segment, Injection Site, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK/BURETROL - 00085412002781 Catalog Number : 2C7564

Device Description : BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Injection Sit BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412002972 Catalog Number : 2C9219

Device Description : Minivolume Extension Set, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412002996 Catalog Number : 2C9221

Device Description : High Flow Rate Extension Set, Luer Lock Adapters

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTRAVIA - 00085412003191 Catalog Number : 2B8012

Device Description : INTRAVIA Container, 250 mL Capacity

Device Class :

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

N/A - 00085412003252 Catalog Number : 2B8066

Device Description : Additive Cap

Device Class :

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 300

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