Dry Bicarb Mixing System BCMIX100

GUDID 00814963021459

ROCKWELL MEDICAL, INC.

Haemodialysis system fluid mixer Haemodialysis system fluid mixer

• Primary Device ID: 00814963021459
• NIH Device Record Key: d2a76b96-dd78-4137-9052-0a43bd355f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dry Bicarb Mixing System
• Version Model Number: BCMIX100
• Catalog Number: BCMIX100
• Company DUNS: 933721433
• Company Name: ROCKWELL MEDICAL, 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
GS1	00814963021459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022521

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: 2018-02-19

Devices Manufactured by ROCKWELL MEDICAL, INC.

• 10814963021487 - RenalPure: 2019-06-25
• 00814963020001 - Sterilyte: 2018-07-06
• 00814963020018 - Sterilyte: 2018-07-06
• 00814963020025 - RenalPure: 2018-07-06
• 00814963020032 - RenalPure: 2018-07-06
• 00814963020049 - RenalPure: 2018-07-06
• 00814963020056 - RenalPure: 2018-07-06
• 00814963020063 - RenalPure: 2018-07-06