Letter Sole Source_CWP_3Jan22.pdf
PDF 29 KB Posted
- Attached to
- J046--P/M Service for Dialysis Reverse Osmosis System Federal contract opportunity
- Solicitation number
- 36C24122Q1209
About this file
This document contains a sole source justification letter and a related federal contract opportunity notice. The sole source justification letter from Evoqua Water Technologies states that they are the sole provider of the CWP 100 H/S dialysis reverse osmosis system and its replacement components in the United States, as they acquired the prior manufacturer and hold the FDA 510(k) clearance for the system as a medical device. The letter details that Evoqua provides installation, training, maintenance, technical support, and consumables for the system to ensure compliance and warranty obligations are met.
The related federal contract opportunity from the Department of Veterans Affairs seeks to award a sole source contract to Evoqua Water Technologies for preventative maintenance and repair services for the CWP 100 H/S dialysis reverse osmosis system at the West Haven VAMC in Connecticut. Interested parties are able to submit capability statements for future procurements by October 5, 2022.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| P03 Part 806.3 Atch7 FAR6 JA OVER SAT signed all.pdf | ||
| 36C24122P1403_1.docx | DOCX document |
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Text version
14550 28th Ave North Plymouth, MN 55447 USA
Tel: (800) 633-3080 Fax: +1 (763) 210-3868
January 3, 2022
Re: Sole Source Justification for the CWP 100 H/S Central Water Plant
To Whom It May Concern, Evoqua Water Technologies, LLC having acquired the Mar Cor Purification, Inc. business on January 2, 2022, is a medical device manufacturer and the sole source provider of the CWP 100 H/S unit and its replacement components for the United States of America. The CWP 100 H/S unit is a Reverse Osmosis (RO) machine identified as a medical device and has an FDA 510(k) clearance. It is exclusively designed to make hemodialysis water quality that meets ANSI/AAMI standards.
The CWP 100 H/S is not marketed through distribution channels or through OEM’s, but sold directly to dialysis providers within hospitals, free-standing clinics, at-home providers, and other institutions that deliver hemodialysis therapies. These units are completely assembled and thoroughly tested in our ISO 13485 compliant, and FDA registered medical device manufacturing facility in Plymouth, Minnesota.
Our company provides installation, onsite product orientation, documented protocols, regional field service technicians, preventative maintenance programs, on-call technical support, user training programs, and a complete line of consumables and spare parts. No other company or business has been given the authority or position to perform and provide technical support both in the field and/or through telecommunications. Evoqua is the only authorized/certified provider for disinfection and preventative maintenance services on this equipment.
If CWP 100 H/S unit parts and consumables are not purchased through a sole source, it would adulterate the medical device clearance, make null and void all applicable warranties, and place unnecessary risk by using non-conforming components. Procuring CWP 100 H/S devices, parts, consumables, and services from Evoqua Water Technologies saves you time and money by offering reliable, safe, and effective equipment and by providing single-source management and delivery, all while insuring you maintain compliance.
If you have any other questions, please contact us at 800-633-3080 or visit our website at www.mcpur.com.
Sincerely, Michael Verguldi Sr. Product Manager
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