GAMBRO RENAL PRODUCTS, INC.

Address:1101 Jeter Avenue,Opelika,AL,36801,US

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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) (4)

Premarket Exempt

Clear

POLYFLUX REVACLEAR - 07332414101695 Catalog Number : 110633

Device Description : Revaclear-Revaclear Max are indicated for the treatment of chronic and acute ren Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

Device Class : 2

Duns Number: 929768682

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

POLYFLUX REVACLEAR MAX - 07332414101701 Catalog Number : 110634

Device Class : 2

Duns Number: 929768682

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

REVACLEAR - 07332414123055 Catalog Number : 114745L

Device Description : Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and a Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis

Device Class : 2

Duns Number: 929768682

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

REVACLEAR - 07332414124076 Catalog Number : 114746L

Device Description : Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal fai Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis

Device Class : 2

Duns Number: 929768682

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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