BICARB, DUAL, 60, MIX/DEL, EDUCTOR EQASSY60BC-2TNK-EB

GUDID BC0121

Bicarbonate mixer with dual 60 gallon tanks, for central mix and delivery in dialysis applications. Uses an eductor pump to mix.

BETTER WATER, LLC

Haemodialysis bicarbonate solution preparation mixer

• Primary Device ID: BC0121
• NIH Device Record Key: 0b3b4479-ecff-4986-bf62-29bc1c78ffef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BICARB, DUAL, 60, MIX/DEL, EDUCTOR
• Version Model Number: EQASSY60BC-2TNK-EB
• Catalog Number: EQASSY60BC-2TNK-EB
• 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	BC0121 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

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: 2024-11-21Bicarbonate mixer with dual 60 gallon tanks, for central mix and delivery in dialysis applications. Uses an eductor pump to mix.
• 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.