MedicaPure

GUDID 00817411020103

Liquid Acid Concentrate

DIMESOL USA, LLC

Haemodialysis concentrate

• Primary Device ID: 00817411020103
• NIH Device Record Key: 2d411837-f0cf-4e75-8099-1ace9bd36440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedicaPure
• Version Model Number: AC-203
• Company DUNS: 069723499
• Company Name: DIMESOL USA, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817411020103 [Primary]
GS1	10817411020100 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901471

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-05

On-Brand Devices [MedicaPure]

• 10817411021039: Liquid Acid Concentrate
• 10817411021015: Liquid Acid Concentrate
• 10817411020490: Liquid Acid Concentrate
• 10817411020438: Liquid Acid Concentrate
• 10817411020339: Liquid Acid Concentrate
• 10817411020162: Liquid Acid Concentrate
• 00817411020110: Liquid Acid Concentrate
• 00817411020103: Liquid Acid Concentrate
• 10817411020087: Liquid Acid Concentrate
• 00817411020073: Liquid Acid Concentrate
• 10817411020063: Liquid Acid Concentrate
• 00817411020059: Liquid Acid Concentrate
• 00817411020042: Liquid Acid Concentrate