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) (9) Stopcock, i.V. Set (FMG) (3) DISPENSER, LIQUID MEDICATION (KYX) (1)

Premarket Exempt

No Yes

Clear

ONE-LINK - 00085412475387 Catalog Number : 7N8301

Device Description : Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neu Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, 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 - 00085412475394 Catalog Number : 2N1333

Device Description : Non-DEHP Standard Bore Catheter Extension Set, Power Injectable, Male Luer Lock Non-DEHP Standard Bore Catheter Extension Set, Power Injectable, 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

ONE-LINK - 00085412475400 Catalog Number : 7N8391

Device Description : Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-free IV Connector w Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, 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

ONE-LINK - 00085412475417 Catalog Number : 7N8390

Device Description : Non-DEHP Microbore Catheter Extension Set, Bonded Needle-free IV Connector with Non-DEHP Microbore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, 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 - 00085412476193 Catalog Number : STP0073

Device Description : Solution Set, Injection Site, Male Luer Lock Adapter, Large Bore Stopcock with R Solution Set, Injection Site, Male Luer Lock Adapter, Large Bore Stopcock with Rotating Male Luer Lock, Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FMG, FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412476223 Catalog Number : STP8325

Device Description : Large Bore Stopcock Minivolume Extension Set, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FMG, FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412476247 Catalog Number : STP5604

Device Description : Large Bore Stopcock Extension Set, Male Luer Lock Adapter with Retractable Collar

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FMG, FPA

Prescription Use : Yes

Device Count : 1

ONE-LINK - 00085412476728 Catalog Number : 7N8310

Device Description : Non-DEHP Microbore Catheter Extension Set, Needle-free IV Connector with Neutral Non-DEHP Microbore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

EXACTAMIX - 00085412480060 Catalog Number : H938711008

Device Description : EXACTAMIX Cap - Large Bore, Internal Thread

Device Class : 1

Duns Number: 005146311

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : Yes

Device Count : 1

CLEARLINK/CONTINU-FLO/DUO-VENT - 00085412486512 Catalog Number : UC8519

Device Description : CONTINU-FLO Solution Set with DUO-VENT Spike, 2 Luer Activated Valves, Male Luer CONTINU-FLO Solution Set with DUO-VENT Spike, 2 Luer Activated Valves, 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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