Gambro Dialysatoren GmbH

Address:HOLGER - CRAFOORD - STRASSE 26,HECHINGEN Baden-Wurttemberg,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) (2) Subsystem, water purification (FIP) (1)

Premarket Exempt

No Yes

Clear

REVACLEAR - 07332414126193 Catalog Number : 114745M

Device Description : Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal f Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.

Device Class : 2

Duns Number: 316150549

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

REVACLEAR - 07332414126209 Catalog Number : 114746M

Device Description : Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal f Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.

Device Class : 2

Duns Number: 316150549

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

U9000 Plus ultrafilter - 07332414126957 Catalog Number : 955825

Device Description : The U9000 Plus Ultrafilter is indicated for purification of incoming water for d The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.

Device Class : 2

Duns Number: 316150549

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

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