GAMBRO INDUSTRIES

Address:7, AV. LIONEL TERRAY, B.P. 126,MEYZIEU CEDEX Rhone,FR

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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) (5) SUBSYSTEM, WATER PURIFICATION (FIP) (1) Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma (MDP) (1)

Premarket Exempt

Clear

PRISMAFLEX SET - 07332414064549 Catalog Number : 106696

Device Description : The Prismaflex M60 set is indicated for use only with the PrismaFlex control uni The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Device Class : 2

Duns Number: 393020474

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

PRISMAFLEX SET - 07332414064556 Catalog Number : 106697

Device Description : The Prismaflex M100 set is indicated for use only with the PrismaFlex control un The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Device Class : 2

Duns Number: 393020474

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

DIACLEAR - 07332414066314 Catalog Number : 106887

Device Description : The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for purification of dialysis fluid to obtain microbiologically high quality dialysis fluid.

Device Class : 2

Duns Number: 393020474

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

PRISMAFLEX SET - 07332414069254 Catalog Number : 107140

Device Description : The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system o The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Device Class : 2

Duns Number: 393020474

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

PRISMAFLEX SET - 07332414069315 Catalog Number : 107142

Device Description : The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system o The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Device Class : 2

Duns Number: 393020474

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

PRISMAFLEX SET - 07332414090005 Catalog Number : 109990

Device Description : The Prismaflex M150 set is indicated for use only with the PrismaFlex control un The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Device Class : 2

Duns Number: 393020474

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

PRISMAFLEX TPE 2000 SET - 07332414111038 Catalog Number : 114093

Device Description : The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

Device Class :

Duns Number: 393020474

Premarket Exempt : No

Product Code : MDP

Prescription Use : Yes

Device Count : 1

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