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) (8) CONTAINER, I.V. (KPE) (2) Stopcock, i.V. Set (FMG) (2)

Premarket Exempt

No Yes

Clear

INTRAVIA - 00085412003467 Catalog Number : 2B8011

Device Description : INTRAVIA Container, 150 mL Capacity

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

INTRAVIA - 00085412003504 Catalog Number : 2B8019

Device Description : INTRAVIA Container, 50 mL Capacity

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

NA - 00085412003818 Catalog Number : 2C5641

Device Description : 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

NA - 00085412003832 Catalog Number : 2C5685

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 - 00085412003849 Catalog Number : 2C5687

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 - 00085412003856 Catalog Number : 2C6217

Device Description : Two Gang Large Bore Stopcock Manifold with Rotating Male Luer Lock

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FMG, FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412003863 Catalog Number : 2C6218

Device Description : Three Gang Large Bore Stopcock Manifold with Rotating Male Luer Lock

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA, FMG

Prescription Use : Yes

Device Count : 1

NA - 00085412003900 Catalog Number : 2C6226

Device Description : 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 - 00085412003917 Catalog Number : 2C6227

Device Description : Extension Set, 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 - 00085412003948 Catalog Number : 2C6419

Device Description : Solution Set with DUO-VENT Spike, Injection Site, Male Luer Lock Adapter with Re Solution Set with DUO-VENT Spike, 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

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