B.Braun Avitum AG

Address:KATTENVENNER STR. 32,GLANDORF Lower Saxony,DE

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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

Dialyzer, high permeability with or without sealed dialysate system (KDI) (5) LIPOPROTEIN, LOW DENSITY, REMOVAL (MMY) (4) Medical device data system (OUG) (1)

Premarket Exempt

No Yes

Clear

B.BRAUN - 04046963686697 Catalog Number : 7105171

Device Description : Dialog+® Hemodialysis System Bicarbonate Cartridge Holder (BIC)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963686710 Catalog Number : 7102244

Device Description : OPTION ACCU DIALOG + SW9.XX

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963686727 Catalog Number : 7102102

Device Description : Dialog+® UltraPure Fluid Hemodialysis System Filter Kit

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963686734 Catalog Number : 7102230

Device Description : Option Nexadia BSL SW 9.xx (7102230)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963686758 Catalog Number : 7102231

Device Description : Option WAN BSL Dialog+ SW 9 (7102231)

Device Class : 1

Duns Number: 343689704

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963686772 Catalog Number : 7102340

Device Description : OPTION 7X10 ROLLER FOR BLOODPUMP SW9.XX

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963711139 Catalog Number : 7210925

Device Description : H.E.L.P.® Plasmat® Futura Treatment Kit

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 4

B.BRAUN - 04046963711153 Catalog Number : 7210927

Device Description : ARTERIAL LINE FUTURA (US)

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 25

B.BRAUN - 04046963711160 Catalog Number : 7210928

Device Description : DIALYSING LINE FUTURA (US)

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 25

B.BRAUN - 04046963711177 Catalog Number : 7210929

Device Description : EMPTY BAG FOR PRIMING SOLUTION FUTURA US

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 25

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