MEDI-PORT PBII R.O. 220V EQROPB01600

GUDID PB0002

Portable reverse osmosis machine for water purification for dialysis applications. 220V.

BETTER WATER, LLC

Combination water purification system

• Primary Device ID: PB0002
• NIH Device Record Key: 2ff9e8e3-3eed-4bf3-8e83-1faaae2f81cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDI-PORT PBII R.O. 220V
• Version Model Number: EQROPB01600
• Catalog Number: EQROPB01600
• 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	PB0002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954928

FDA Product Code

• FIP: Subsystem, Water Purification

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: 2024-11-21 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: 2024-11-21Portable reverse osmosis machine for water purification for dialysis applications. 220V.
• 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.