POST-TREAT, .03 30", 208V

Basic Information

• Brand Name: POST-TREAT, .03 30", 208V
• Primary DI: PS0155
• Version / Model: WM-PST-303-OO-1GJ
• Catalog Number: WM-PST-303-OO-1GJ
• 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: e989d779-8fa3-45b6-834b-77489d8957f7

Device Description

Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, particulate filter, DI header, 1 pump, and divert-to-drain. 208V.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44344	Combination water purification system	An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	PS0155	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K920186	000