Concentrate Distribution System

Basic Information

• Brand Name: Concentrate Distribution System
• Primary DI: B297ACDS70O0
• Version / Model: A-CDS-70-O
• Company Name: SPECIALITY WATER TECHNOLOGY
• Labeler DUNS: 032528935
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-11
• Public Version: 3
• Public Version Date: 2018-05-15
• Public Version Status: Update
• Public Device Record Key: 1b0e437d-0137-4a42-953c-0f6e8a2dc2dd
• Distribution End Date: 2017-04-11

Device Description

Concentrate Distribution System (mounted on stand) for Primary Concentrate System-Orange

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: Yes
• 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
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	B297ACDS70O0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]