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) (6) ARTHROSCOPE (HRX) (4) System, irrigation, urological (LJH) (4) Stopcock, i.V. Set (FMG) (1)

Premarket Exempt

No Yes

Clear

NA - 00085412001029 Catalog Number : 2C4030

Device Description : Two Lead Arthroscopic Irrigation Set

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : HRX, LJH

Prescription Use : Yes

Device Count : 1

NA - 00085412001036 Catalog Number : 2C4031

Device Description : Four Lead Arthroscopic Irrigation Set

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : HRX, LJH

Prescription Use : Yes

Device Count : 1

NA - 00085412001050 Catalog Number : 2C4040

Device Description : Cysto/Bladder Irrigation Set, Regulating Clamp

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : HRX, LJH

Prescription Use : Yes

Device Count : 1

NA - 00085412001067 Catalog Number : 2C4041

Device Description : Y-Type TUR/Bladder Irrigation Set, Regulating Clamp

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : LJH, HRX

Prescription Use : Yes

Device Count : 1

NA - 00085412001814 Catalog Number : 2C5645

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 - 00085412001913 Catalog Number : 2C6204

Device Description : Large Bore Stopcock with Rotating Male Luer Lock

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA, FMG

Prescription Use : Yes

Device Count : 1

INTERLINK - 00085412002118 Catalog Number : 2C6401

Device Description : Solution Set, Injection Site, Lever Lock Cannula, Male Luer Lock Adapter with Re Solution Set, Injection Site, Lever Lock Cannula, 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 - 00085412002125 Catalog Number : 2C6402

Device Description : Solution Set, Injection Site, Lever Lock Cannula, Male Luer Lock Adapter with Re Solution Set, Injection Site, Lever Lock Cannula, 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 - 00085412002132 Catalog Number : 2C6424

Device Description : 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 - 00085412002149 Catalog Number : 2C6425

Device Description : 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

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