Sodium Bicarbonate Mixing and Distribution System

GUDID 00852456007085

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

ISOPURE, CORP.

Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer Haemodialysis system fluid mixer
Primary Device ID00852456007085
NIH Device Record Key464d5635-080f-431f-8285-555807df6977
Commercial Distribution StatusIn Commercial Distribution
Brand NameSodium Bicarbonate Mixing and Distribution System
Version Model NumberIsoMix PRO
Company DUNS040279650
Company NameISOPURE, CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852456007085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FINTank, Holding, Dialysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-20

Devices Manufactured by ISOPURE, CORP.

00852456007108 - Acid Dissolution System2024-02-22 Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00852456007115 - Acid Dissolution System2024-02-22 Dialysate Concentrate For Hemodialysis (Liquid or Powder)
00852456007009 - MD420 Reverse Osmosis System2018-07-06 MD420 Reverse Osmosis System
00852456007016 - MD440 Reverse Osmosis System2018-07-06 MD440 Reverse Osmosis System
00852456007023 - MD460 Reverse Osmosis System2018-07-06 MD460 Reverse Osmosis System
00852456007030 - MD470 Reverse Osmosis System2018-07-06 MD470 Reverse Osmosis System
00852456007047 - MD480 Reverse Osmosis System2018-07-06 MD480 Reverse Osmosis System
00852456007054 - MD490 Reverse Osmosis System2018-07-06 MD490 Reverse Osmosis System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.