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, CAPILLARY, HOLLOW FIBER (FJI) (5) Dialyzer, high permeability with or without sealed dialysate system (KDI) (5) LIPOPROTEIN, LOW DENSITY, REMOVAL (MMY) (5)

Premarket Exempt

No Yes

Clear

B.BRAUN - 04046964290138 Catalog Number : 4103

Device Description : HELP 0,9 % SODIUM CHL. SET US 500/1500ML

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 4

B.BRAUN - 04046964290145 Catalog Number : 4107

Device Description : HELP 0,9 % SODIUM CHLORIDE US 3000ML

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 4

B.BRAUN - 04046964290152 Catalog Number : 4109

Device Description : HELP BIC EL HCL US 5000ML

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 2

B.BRAUN - 04046964290169 Catalog Number : 4113

Device Description : HELP ACETATE BUFFER 4.85 US 3000ML

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 4

B.BRAUN - 04046964319860 Catalog Number : 7061188

Device Description : H.E.L.P. Heparin Sodium Solution 30 mL

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : MMY

Prescription Use : Yes

Device Count : 80

Diacap® - 04046964319891 Catalog Number : 7204000

Device Description : DIACAP LOPS 10 PS DIALYZER

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI, FJI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964319921 Catalog Number : 7204001

Device Description : Diacap? Polysulfone® LOPS 12

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : FJI, KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964319945 Catalog Number : 7204002

Device Description : Diacap Polysulfone® LO PS 15 Dialyzer

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : FJI, KDI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964319969 Catalog Number : 7204100

Device Description : Diacap Polysulfone® HI PS 10 Dialyzer

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI, FJI

Prescription Use : Yes

Device Count : 20

Diacap® - 04046964319983 Catalog Number : 7204101

Device Description : DIACAP HIPS 12 PS DIALYZER

Device Class :

Duns Number: 343689704

Premarket Exempt : No

Product Code : KDI, FJI

Prescription Use : Yes

Device Count : 20

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