Acid Dissolution System

GUDID 00852456007115

Dialysate Concentrate For Hemodialysis (Liquid or Powder)

Isopure, Corp.

Haemodialysis concentrate

• Primary Device ID: 00852456007115
• NIH Device Record Key: d8b5a377-48ea-43b9-ac05-f38ff756f82b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acid Dissolution System
• Version Model Number: MD70510
• 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	00852456007115 [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)