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 For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.

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 For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System.Sterile Fluid Path.

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 Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path

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 Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Sterile Fluid Path

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 LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. Sterile Fluid Path

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 Blood Component Infusion Set- Standard Blood Component Filter Female Luer. Sterile Fluid Path

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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