Acid Dissolution System

GUDID 00852456007115

Dialysate Concentrate For Hemodialysis (Liquid or Powder)

Isopure, Corp.

Haemodialysis concentrate
Primary Device ID00852456007115
NIH Device Record Keyd8b5a377-48ea-43b9-ac05-f38ff756f82b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcid Dissolution System
Version Model NumberMD70510
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
GS100852456007115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-22
Device Publish Date2024-02-14

On-Brand Devices [Acid Dissolution System]

00852456007115Dialysate Concentrate For Hemodialysis (Liquid or Powder)
00852456007108Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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