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) Set, blood transfusion (BRZ) (2)

Premarket Exempt

No Yes

Clear

INTERLINK - 00085412003955 Catalog Number : 2C6606

Device Description : Extension 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 - 00085412003962 Catalog Number : 2C6612

Device Description : Extension 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 - 00085412003993 Catalog Number : 2C6671

Device Description : Extension Set, 0.2 Micron Filter Injection Site, Male Luer Lock Adapter with Ret Extension Set, 0.2 Micron Filter 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

INTERLINK - 00085412004006 Catalog Number : 2C6720

Device Description : Y-Type Blood/Solution Set with Standard Blood Filter, 170 to 260 Micron Filter, Y-Type Blood/Solution Set with Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

INTERLINK/CONTINU-FLO/CONTROL-A-FLO - 00085412004037 Catalog Number : 2C6895

Device Description : CONTINU-FLO Solution Set with CONTROL-A-FLO Regulator, 2 Injection Sites, Male L CONTINU-FLO Solution Set with CONTROL-A-FLO Regulator, 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

NA - 00085412004112 Catalog Number : 2C7554

Device Description : Solution Set, Male Luer Lock Adapter with Retractable Collar For Epidural Use

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

NA - 00085412004136 Catalog Number : 2C7627

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

NA - 00085412004174 Catalog Number : 2C9201

Device Description : Microbore 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 - 00085412004198 Catalog Number : 2C9203

Device Description : Microbore 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 - 00085412004235 Catalog Number : 2C9216

Device Description : Anesthesia Set, Male Luer Lock Adapter

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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