B.Braun Avitum AG

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

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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

Dialyzer, high permeability with or without sealed dialysate system (KDI) (6) DIALYZER, CAPILLARY, HOLLOW FIBER (FJI) (3) LIPOPROTEIN, LOW DENSITY, REMOVAL (MMY) (3) Medical device data system (OUG) (1)

Premarket Exempt

No Yes

Clear

Diacap® - 04046964320002 Catalog Number : 7204102

Device Description : Diacap Polysulfone® HI PS 15 Dialyzer

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : FJI, KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964320026 Catalog Number : 7204103

Device Description : Diacap Polysulfone® HI PS 18 Dialyzer

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI, FJI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964320040 Catalog Number : 7204104

Device Description : Diacap Polysulfone® HI PS 20 Dialyzer

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI, FJI

Prescription Use : Yes

Device Count : 20

B.BRAUN - 04046964337017 Catalog Number : 706210A

Device Description : The Plasmat® Futura System

Device Class : 3

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 1

Diacap® - 04046964610776 Catalog Number : 720DH13

Device Description : Diacap® Pro 13H

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964610813 Catalog Number : 720DH19

Device Description : Diacap® Pro 19H

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964610837 Catalog Number : 720DH16

Device Description : Diacap® Pro 16H

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 20

B.BRAUN - 04046964689253 Catalog Number : 7107231

Device Description : Option WAN BSL Dialog+ SW 7/8 (7107231)

Device Class : 1

Duns Number: 343689704

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

H.E.L.P.® - 04046964695865 Catalog Number : 7211094

Device Description : HELP HOT FUTURA SET US

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 4

H.E.L.P.® - 04046964696770 Catalog Number : 7211101

Device Description : HELP ULTRAFILTER HIPS 20 US

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 20

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