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

• BC0021 - BICARB, DUAL, 100, MIX/DEL, EDUCTOR: 2024-11-21 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications. Uses an eductor pump to mi
• BC0121 - BICARB, DUAL, 60, MIX/DEL, EDUCTOR: 2024-11-21 Bicarbonate mixer with dual 60 gallon tanks, for central mix and delivery in dialysis applications. Uses an eductor pump to mix
• PB0002 - MEDI-PORT PBII R.O. 220V: 2024-11-21 Portable reverse osmosis machine for water purification for dialysis applications. 220V.
• PB0003 - MEDI-PORT PBII R.O. 120V: 2024-11-21 MEDI-PORT PBII R.O. 120V
• PR0023 - PRETREAT, 1", 208V, CPVC, SHORT, AC: 2024-11-21 Pretreatment rack with control box and blend valve. 1" piping, CPVC, 208V AC, short version.
• PS0155 - POST-TREAT, .03 30", 208V: 2024-11-21 Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, particulate filter,
• 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.