Fresenius Kabi AG

Address:Fresenius Kabi AB,Uppsala,SE

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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

Pump, Infusion (FRN) (7) Supplies, Blood-Bank (KSS) (2) Separator, Automated, Blood Cell And Plasma, Therapeutic (LKN) (1)

Premarket Exempt

No Yes

Clear

CompoMaster Net G5 - 04086000860581 Catalog Number : 9025571

Device Description : The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood co The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation.

Device Class : 1

Duns Number: 315654579

Premarket Exempt : No

Product Code : KSS

Prescription Use : No

Device Count : 1

TPE Plasma Exchange Set - 04086000901543 Catalog Number : 9400451

Device Description : Therapeutic plasma exchange, disposable variant of 9400401 (Therapeutic plasma e Therapeutic plasma exchange, disposable variant of 9400401 (Therapeutic plasma exchange, red blood cell exchange).

Device Class : U

Duns Number: 315654579

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

Fenwal Plasma Extractor - 04086000903226 Catalog Number : 4R4414

Device Description : Fenwal Plasma Extractor

Device Class :

Duns Number: 315654579

Premarket Exempt : Yes

Product Code : KSS

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714180 Catalog Number : M46443160

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714234 Catalog Number : M46445460

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714258 Catalog Number : M46445660

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714272 Catalog Number : M46441960

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714296 Catalog Number : M46445670

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714319 Catalog Number : M46445270

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Volumat™ Line - 04250273714333 Catalog Number : M46445860

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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