BiPro Bicarb Mixing/Distribution System

GUDID B285SDSCB2001

MEDICAL SOLUTIONS INTERNATIONAL, INC.

Haemodialysis system bicarbonate mixer Haemodialysis system bicarbonate mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer Haemodialysis bicarbonate solution preparation mixer

• Primary Device ID: B285SDSCB2001
• NIH Device Record Key: 7ab54a88-6f49-4042-a62a-90158fde7bb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiPro Bicarb Mixing/Distribution System
• Version Model Number: SDS-CB200
• Company DUNS: 926740010
• Company Name: MEDICAL SOLUTIONS INTERNATIONAL, INC.
• 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: false
• 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
HIBCC	B285SDSCB2001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033118

FDA Product Code

• FIN: Tank, Holding, Dialysis

Sterilization

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

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

[B285SDSCB2001]

Hydrogen Peroxide;Ozone

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-30