FENWAL, INC.

Address:3 CORPORATE DR STE 300,LAKE ZURICH,IL,60047,US

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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

Microfilter, Blood Transfusion (CAK) (4) Set, Blood Transfusion (BRZ) (3) Separator, Automated, Blood Cell, Diagnostic (GKT) (2) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (1)

Premarket Exempt

No Yes

Clear

ALYX™ 2RBC-LR Kit - 00811137010127 Catalog Number : 4R5720

Device Description : For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. Fo

Device Class : 2

Duns Number: 794519020

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

ALYX™ RBC/Plasma Kit - 00811137010134 Catalog Number : 4R5700

Device Description : For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma

Device Class :

Duns Number: 794519020

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

NA - 00811137010400 Catalog Number : 4C2161

Device Description : Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter

Device Class : 2

Duns Number: 794519020

Premarket Exempt : No

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

NA - 00811137010431 Catalog Number : 4C4502

Device Description : Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path

Device Class : 2

Duns Number: 794519020

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

NA - 00811137010455 Catalog Number : 4C2160

Device Description : Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Ster

Device Class : 2

Duns Number: 794519020

Premarket Exempt : No

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

NA - 00811137010462 Catalog Number : 4C2300

Device Description : SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path

Device Class :

Duns Number: 794519020

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

Leukoconnect - 00811137010486 Catalog Number : 4C4300

Device Description : LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-200

Device Class :

Duns Number: 794519020

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

NA - 00811137010691 Catalog Number : 4C2223

Device Description : Blood Component Infusion Set- Standard Blood Component Filter Female Luer. Steri

Device Class : 2

Duns Number: 794519020

Premarket Exempt : No

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

NA - 00811137010714 Catalog Number : 4C2468

Device Description : SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path

Device Class : 2

Duns Number: 794519020

Premarket Exempt : No

Product Code : CAK

Prescription Use : Yes

Device Count : 1

Transfer Pack - 00811137010738 Catalog Number : 4R2027

Device Description : Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path

Device Class :

Duns Number: 794519020

Premarket Exempt : Yes

Product Code : KSR

Prescription Use : Yes

Device Count : 1

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