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) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) (KPO) (3) SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT (FKQ) (1)

Premarket Exempt

No Yes

Clear

Diacap® - 04039239090496 Catalog Number : 7107367

Device Description : Diacap® Ultra Dialysis Fluid Filters

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : FKQ

Prescription Use : Yes

Device Count : 6

Diacap® - 04046955659623 Catalog Number : 720DH13G

Device Description : Diacap Pro 13H G

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046955659647 Catalog Number : 720DH16G

Device Description : Diacap Pro 16H G

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046955659661 Catalog Number : 720DH19G

Device Description : Diacap Pro 19H G

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 20

Sol-Cart B® - 04046963332709 Catalog Number : 802

Device Description : Solcart B® Bicarbonate Cartridge 650 grams

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 10

Sol-Cart B® - 04046963332730 Catalog Number : 803

Device Description : Solcart B® Bicarbonate Cartridge 760 grams

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 10

Sol-Cart B® - 04046963621599 Catalog Number : 805

Device Description : Solcart B® Bicarbonate Cartridge 1100 grams

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 8

Dialog+® - 04046963686338 Catalog Number : 710200K

Device Description : Dialog+® Evolution Hemodialysis System

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Dialog+® - 04046963686345 Catalog Number : 710200L

Device Description : Dialog+® Hemodialysis System with BIC Holder for Bicarbonate Cartridge

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04046963686680 Catalog Number : 7102226

Device Description : OPTION ABPM DIALOG+ SW9.XX

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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