BICARB, DUAL, 100, MIX/DEL, EDUCTOR

Basic Information

• Brand Name: BICARB, DUAL, 100, MIX/DEL, EDUCTOR
• Primary DI: BC0021
• Version / Model: EQASSY100BC-2TNK-EB
• Catalog Number: EQASSY100BC-2TNK-EB
• Company Name: BETTER WATER, LLC
• Labeler DUNS: 055252159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-13
• Public Version: 1
• Public Version Date: 2024-11-21
• Public Version Status: New
• Public Device Record Key: 221b51a2-9136-4f6b-bfe6-870e6863f01b

Device Description

Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications. Uses an eductor pump to mix.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIN	Tank, Holding, Dialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36345	Haemodialysis bicarbonate solution preparation mixer	An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solution delivery features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	BC0021	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K992793	000