Acid Dissolution System

GUDID 00852456007108

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Isopure, Corp.

Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate

Primary Device ID	00852456007108
NIH Device Record Key	c59051e4-d6de-4e2b-a19a-d09bab0c96a4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Acid Dissolution System
Version Model Number	MD70500
Company DUNS	040279650
Company Name	Isopure, Corp.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852456007108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191093

FDA Product Code

KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-02-22
Device Publish Date	2024-02-14

On-Brand Devices [Acid Dissolution System]

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