Complete Water Treatment System

GUDID 00852456007078

Complete Water Treatment System for Hemodialysis

ISOPURE, CORP.

Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system Combination water purification system

• Primary Device ID: 00852456007078
• NIH Device Record Key: 1532b21e-9ea3-4fa3-9d0a-7f099c2885db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Complete Water Treatment System
• Version Model Number: 001
• 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: false
• 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	00852456007078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041163

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-20

Devices Manufactured by ISOPURE, CORP.

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• 00852456007115 - Acid Dissolution System: 2024-02-22 Dialysate Concentrate For Hemodialysis (Liquid or Powder)
• 00852456007009 - MD420 Reverse Osmosis System: 2018-07-06 MD420 Reverse Osmosis System
• 00852456007016 - MD440 Reverse Osmosis System: 2018-07-06 MD440 Reverse Osmosis System
• 00852456007023 - MD460 Reverse Osmosis System: 2018-07-06 MD460 Reverse Osmosis System
• 00852456007030 - MD470 Reverse Osmosis System: 2018-07-06 MD470 Reverse Osmosis System
• 00852456007047 - MD480 Reverse Osmosis System: 2018-07-06 MD480 Reverse Osmosis System
• 00852456007054 - MD490 Reverse Osmosis System: 2018-07-06 MD490 Reverse Osmosis System