ISOPURE, CORP.

Address:11851 Plantside Drive,Louisville,KY,40299,US

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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

Subsystem, Water Purification (FIP) (7) Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (KPO) (1) Tank, Holding, Dialysis (FIN) (1)

Premarket Exempt

Clear

MD420 Reverse Osmosis System - 00852456007009 Catalog Number :

Device Description : MD420 Reverse Osmosis System

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

MD440 Reverse Osmosis System - 00852456007016 Catalog Number :

Device Description : MD440 Reverse Osmosis System

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

MD460 Reverse Osmosis System - 00852456007023 Catalog Number :

Device Description : MD460 Reverse Osmosis System

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

MD470 Reverse Osmosis System - 00852456007030 Catalog Number :

Device Description : MD470 Reverse Osmosis System

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

MD480 Reverse Osmosis System - 00852456007047 Catalog Number :

Device Description : MD480 Reverse Osmosis System

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

MD490 Reverse Osmosis System - 00852456007054 Catalog Number :

Device Description : MD490 Reverse Osmosis System

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

Complete Water Treatment System - 00852456007078 Catalog Number :

Device Description : Complete Water Treatment System for Hemodialysis

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

Sodium Bicarbonate Mixing and Distribution System - 00852456007085 Catalog Number :

Device Description : IsoMix PRO Sodium Bicarbonate Mixing and Distribution System (MD702480-SS)

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : FIN

Prescription Use : No

Device Count : 1

Acidified Concentrate Distribution and Storage (ACDS) System - 00852456007092 Catalog Number :

Device Description : Acidified Concentrate Distribution and Storage System (ACDS System)

Device Class : 2

Duns Number: 040279650

Premarket Exempt : No

Product Code : KPO

Prescription Use : No

Device Count : 1

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