BICARB, SINGLE, 60, MIX-ONLY EQASSY60BICARB

GUDID BC0302

Bicarbonate mixer with a single 60 gallon tank for mixing only (no delivery) in dialysis applications.

BETTER WATER, LLC

Haemodialysis system bicarbonate mixer

• Primary Device ID: BC0302
• NIH Device Record Key: 41899728-d84b-4d5d-8c91-84017b24ab86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BICARB, SINGLE, 60, MIX-ONLY
• Version Model Number: EQASSY60BICARB
• Catalog Number: EQASSY60BICARB
• Company DUNS: 055252159
• Company Name: BETTER WATER, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	BC0302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992793

FDA Product Code

• FIN: Tank, Holding, Dialysis

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: 2016-10-13

Devices Manufactured by BETTER WATER, LLC

• PR0011 - MATRIX -PRETREAT, 1", 230V, CPVC: 2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1" piping, pump, CPVC, 230V.
• PR0012 - MATRIX-PRETREAT, 1" 208V, CPVC: 2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1" piping, pump, CPVC, 208V.
• PR0013 - MATRIX-PRETREAT, 1.5", 230V, CPVC: 2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1.5" piping, pump, CPVC, 230V.
• PR0014 - MATRIX-PRETREAT, 1.5", 208V, CPVC: 2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1.5" piping, pump, CPVC, 208V.
• BC0001 - BICARB, DUAL, 100, MIX/DEL: 2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications.
• BC0002 - BICARB, DUAL, 100, MIX/DEL/1000: 2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications, with large pump for longer
• BC0011 - BICARB, DUAL, 100, MIX/DEL, SP: 2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications. Short profile height.
• BC0012 - BICARB, DUAL, 100, MIX/DEL/1000, SP: 2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications, with large pump for longer