Renasol Bicarbonate Concentrate Powder

GUDID 30677964000349

MEDIVATORS INC.

Haemodialysis concentrate

• Primary Device ID: 30677964000349
• NIH Device Record Key: bd30c2b4-b17f-4ff6-b5d1-65ea5f700058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasol Bicarbonate Concentrate Powder
• Version Model Number: BC-1-15
• Company DUNS: 068199363
• Company Name: MEDIVATORS 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: false
• 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
GS1	00677964000348 [Primary]
GS1	30677964000349 [Package]; Contains: 00677964000348; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843963

FDA Product Code

• FKQ: System, Dialysate Delivery, Central Multiple Patient

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

On-Brand Devices [Renasol Bicarbonate Concentrate Powder]

• 30677964000356: BC-1-25
• 30677964000349: BC-1-15
• 30677964000332: BC-1