MedicaLyte

GUDID 30817411021095

Liquid Bicarbonate Concentrate

DIMESOL USA, LLC

Haemodialysis concentrate

• Primary Device ID: 30817411021095
• NIH Device Record Key: cb559d41-ced9-4215-9eb7-8be26aa08916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedicaLyte
• Version Model Number: BC-200
• 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	00817411021094 [Primary]
GS1	30817411021095 [Package]; Contains: 00817411021094; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012547

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: 2018-08-27
• Device Publish Date: 2018-07-25

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