BAXTER INTERNATIONAL INC.

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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, administration, intravascular (FPA) (9) Filter, infusion line (FPB) (1)

Premarket Exempt

No Yes

Clear

NA - 00085412004259 Catalog Number : 2C9218

Device Description : Universal Anesthesia Set, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412004358 Catalog Number : 2C9292

Device Description : Lever Lock Cannula with Check Valve

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412004532 Catalog Number : 2N1191

Device Description : Non-DEHP Y-Type Catheter 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 - 00085412004617 Catalog Number : 2N1206

Device Description : Non-DEHP Catheter Extension Set, 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 - 00085412004648 Catalog Number : 2N3326

Device Description : Non-DEHP T-Connector Extension Set, T Housing, Male Luer Slip T-Connector

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412004655 Catalog Number : 2N3327

Device Description : Non-DEHP T-Connector Extension Set, T Housing, Rotating T-Connector

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412004662 Catalog Number : 2N3328

Device Description : Non-DEHP T-Connector Extension Set, T Housing, Rotating T-Connector

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412004716 Catalog Number : 2N3333

Device Description : Non-DEHP T-Connector Catheter Extension Set, T-Housing, 0.2 Micron Filter, Rotat Non-DEHP T-Connector Catheter Extension Set, T-Housing, 0.2 Micron Filter, Rotating T-Connector

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412004747 Catalog Number : 2N3339

Device Description : Non-DEHP T-Connector Extension Set, T Housing, Retractable T-Connector

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412004754 Catalog Number : 2N3340

Device Description : Non-DEHP T-Connector Extension Set, T housing, Retractable T-Connector

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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