Renasol Bicarbonate Concentrate Powder

GUDID 30677964000332

MEDIVATORS INC.

Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate

• Primary Device ID: 30677964000332
• NIH Device Record Key: f8b76a0a-9f33-46d5-b2ff-a4bf338fe549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasol Bicarbonate Concentrate Powder
• Version Model Number: BC-1
• 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	00677964000331 [Primary]
GS1	30677964000332 [Package]; Contains: 00677964000331; Package: Case [20 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