MedicaLyte

GUDID 10817411020322

Bicarbonate Powder

DIMESOL USA, LLC

Haemodialysis concentrate

• Primary Device ID: 10817411020322
• NIH Device Record Key: aad39f65-9ae6-4402-b119-8b4b4079dfc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedicaLyte
• Version Model Number: DB-201-25
• 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	00817411020325 [Primary]
GS1	10817411020322 [Package]; Contains: 00817411020325; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131202

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: 2016-11-11

On-Brand Devices [MedicaLyte]

• 30817411021095: Liquid Bicarbonate Concentrate
• 10817411020322: Bicarbonate Powder
• 10817411020278: Bicarbonate Powder
• 10817411020261: Liquid Bicarbonate Concentrate
• 10817411020254: Liquid Bicarbonate Concentrate
• 10817411020247: Liquid Bicarbonate Concentrate