116 results
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42ms
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Sources: EU EUDAMED, US FDA
ISOPURE, CORP.
FDA registration
ISOPURE, CORP.·3 products·🇺🇸 United States
MD460 Reverse Osmosis System
FDA UDI
Isopure, Corp.·00852456007023·MD460 Reverse Osmosis System
Acidified Concentrate Distribution and Storage (ACDS) System
FDA UDI
Isopure, Corp.·00852456007092·Acidified Concentrate Distribution and Storage ...
MD490 Reverse Osmosis System
FDA UDI
Isopure, Corp.·00852456007054·MD490 Reverse Osmosis System
Acid Dissolution System
FDA UDI
Isopure, Corp.·00852456007115·Dialysate Concentrate For Hemodialysis (Liquid ...
MD440 Reverse Osmosis System
FDA UDI
Isopure, Corp.·00852456007016·MD440 Reverse Osmosis System
MD480 Reverse Osmosis System
FDA UDI
Isopure, Corp.·00852456007047·MD480 Reverse Osmosis System
MD470 Reverse Osmosis System
FDA UDI
Isopure, Corp.·00852456007030·MD470 Reverse Osmosis System
Sodium Bicarbonate Mixing and Distribution System
FDA UDI
Isopure, Corp.·00852456007085·IsoMix PRO Sodium Bicarbonate Mixing and Distri...
MD420 Reverse Osmosis System
FDA UDI
Isopure, Corp.·00852456007009·MD420 Reverse Osmosis System
Acid Dissolution System
FDA UDI
Isopure, Corp.·00852456007108·Dialysate Concentrate For Hemodialysis (Liquid ...
Complete Water Treatment System
FDA UDI
Isopure, Corp.·00852456007078·Complete Water Treatment System for Hemodialysis
Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.
FDA Recall
Terminated
·Isopure Corp·Product code FJP·May 19, 2011
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Recall
Terminated
·Isopure Corp·Product code KPO·April 19, 2019
Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step
FDA Recall
Terminated
·Isopure Corp·Product code KPO·October 24, 2011