Fresenius Kabi AG

Address:Fresenius Kabi AB,Uppsala,SE

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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

Separator, Automated, Blood Cell, Diagnostic (GKT) (1)

Premarket Exempt

No Yes

Clear

Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter - M5264C23041 Catalog Number : 4C2304

Device Description : For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile F For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.

Device Class :

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 3

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