B.Braun Avitum AG

B.Braun Avitum AG

Address:Am Buschberg 1,MELSUNGEN Hesse,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) (10) SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC (LKN) (1)

Premarket Exempt

No Yes

Clear

B.BRAUN - 04039239040729 Catalog Number : 7102372

Device Description : ABPM Cuff (small) (7102372)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239040743 Catalog Number : 7102380

Device Description : ABPM Cuff (large) (7102380)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239040859 Catalog Number : 7102771

Device Description : ABPM Cuff (medium) (7102771)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Diapact® - 04039239041252 Catalog Number : 7106510

Device Description : Diapact® CRRT System

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI, LKN

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239041733 Catalog Number : 7107218

Device Description : DCI CABLE

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239070436 Catalog Number : 7105102

Device Description : Dialysis fluid filter (7105102)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239070443 Catalog Number : 7105170

Device Description : Bicarbonate cartridge (7105170)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239070450 Catalog Number : 7105196

Device Description : Central concentrate supply (7105196)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239070467 Catalog Number : 7105226

Device Description : ABPM (7105226)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

B.BRAUN - 04039239070474 Catalog Number : 7105244

Device Description : Emergency (standby) power supply (7105244)

Device Class : 2

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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