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

ARTHROSCOPE (HRX) (3) SYSTEM/DEVICE, PHARMACY COMPOUNDING (NEP) (3) Set, administration, intravascular (FPA) (3) System, irrigation, urological (LJH) (3) CONTAINER, I.V. (KPE) (1)

Premarket Exempt

No Yes

Clear

INTRAVIA - 00085412000046 Catalog Number : 2B8014

Device Description : INTRAVIA Container, 1000 mL Capacity

Device Class :

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

NA - 00085412000077 Catalog Number : 2B8044

Device Description : Large Hand Sealer Clips

Device Class :

Duns Number: 005146311

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : Yes

Device Count : 1000

NA - 00085412000084 Catalog Number : 2B8045

Device Description : Small Hand Sealer Clips

Device Class :

Duns Number: 005146311

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : Yes

Device Count : 1000

NA - 00085412000343 Catalog Number : 2C0415

Device Description : Solution Transfer Set, Needle Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412000503 Catalog Number : 2C1103

Device Description : Non-DEHP Extension Set with 1.2 Micron Downstream Filter, Air Eliminating Filter Non-DEHP Extension Set with 1.2 Micron Downstream Filter, Air Eliminating Filter, INTERLINK Injection Site

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

INTERLINK/CONTINU-FLO - 00085412000527 Catalog Number : 2H6519

Device Description : Non-DEHP CONTINU-FLO Solution Set, 2 Injection Sites, Male Luer Lock Adapter wit Non-DEHP CONTINU-FLO Solution Set, 2 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

INTERLINK - 00085412000541 Catalog Number : 2H7451

Device Description : Non-DEHP 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

NA - 00085412000978 Catalog Number : 2C4005

Device Description : Y-Type TUR Irrigation Set

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : HRX, LJH

Prescription Use : Yes

Device Count : 1

NA - 00085412000985 Catalog Number : 2C4006

Device Description : TUR Series Set

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : HRX, LJH

Prescription Use : Yes

Device Count : 1

NA - 00085412001005 Catalog Number : 2C4014

Device Description : Decanting Set

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : HRX, LJH

Prescription Use : Yes

Device Count : 1

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