P03_SSJ 36C241-26-AP-1948 Transonic HD03 mjc 1_Redacted.pdf
PDF 423 KB Posted
- Attached to
- 6515--HD03 Hemodialysis Flow System - Transonic Systems Federal contract opportunity
- Solicitation number
- 36C24126Q0352
About this file
This is a Justification for Single Source Award filed by the Department of Veterans Affairs, VISN 01, Contracting Office 01, supporting VA Providence Medical Center in Providence, Rhode Island. The acquisition (ID# 36C241-26-AP-1948) is for medical equipment over the micro-purchase threshold but not exceeding the simplified acquisition threshold. The required items are two HD03 Monitors, two H4FX Sensors for the HD03, and two Patient MEAS MOD without PAT ID IN components, all manufactured by SB Transonic Systems, Inc.
The justification establishes that the HD03 Hemodialysis Flow System is the only standalone portable monitor in the marketplace that can measure hemodialysis patient parameters without requiring additional intravenous lines. The device provides real-time flow and volume measurements critical for monitoring arteriovenous access fistulas and grafts, detecting stenosis, assessing vascular access health, and ensuring dialysis adequacy and optimal treatment delivery for veterans. Market research conducted across multiple databases (Sam.gov, SBA, and GSA Advantage) using NAICS code 334510 and various keyword combinations for hemodialysis, Transonic, and related terms yielded no competing Service-Disabled Veteran-Owned Small Businesses or Veteran-Owned Small Businesses. A market research survey confirmed that Transonic Systems is the sole manufacturer and distributor of this portable hemodialysis flow system with no competitors currently in the marketplace. The contracting officer, Manasés Cabrera, certified the justification as accurate and complete, with digital signature dated March 20, 2026. Supporting documentation includes a Sole Manufacturer Notice from Transonic Systems Inc. dated September 30, 2024, confirming their exclusive manufacturing status.
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| 36C24126Q0352.docx | DOCX document |
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Text version
Acquisition ID#36C241-26-AP-1948
DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards For
Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold
Acquisition Plan Action ID: 36C241-26-AP-1948
1. Contracting Activity: Department of Veterans Affairs, VISN 01, Contracting Office
01, in support of VA Providence Medical Center, 830 Chalkstone Avenue, Providence, RI 02908.
2237: 650-26-2-7821-0075
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
Item No. Description Quantity HD03 HD03 Monitor 2 H4FX H4FX Sensor for the HD03 2 PMM Patient MEAS MOD w/o PAT ID IN 2
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
The HD03 Hemodialysis Flow System, manufactured by SB Transonic Systems, Inc., is a specialized portable device critical for the monitoring and optimization of hemodialysis applications. It is a flow and volume measurement system that helps healthcare professionals monitor and evaluate the performance of dialysis treatments. These real time measurement results identify dose delivery problems in the AV access and central venous catheters allowing healthcare providers on the spot to identify any issues providing optimal treatment for veterans. Additionally, the Transonic HD03 helps in assessing the health of vascular access (such as fistulas and grafts) by detecting stenosis or other abnormalities. It aids in ensuring the adequacy of dialysis treatment by providing critical information about flow rates. The device is typically non-invasive, which means it can perform measurements oftentimes without the need for additional surgical procedures.
The HD03 Hemodialysis Flow System is currently the only standalone portable monitor in the marketplace that does not require additional IV lines to go into the
Acquisition ID#36C241-26-AP-1948 veteran and can monitor the lines coming directly from the dialysis machine. It supports the overall quality control of hemodialysis by providing data that can be used to optimize treatment parameters for veterans.
4. Description of market research conducted and results or statement why it was not conducted:
A search was conducted on Sam.gov utilizing NAICS 334510 and over 500 SDVOSBs were identified. Keyword “Transonic” was added and 0 results were displayed. A search on SBA was then conducted with NAICS 334510 and over 400 SDVOSBs were identified. Keyword “transonic” was then added and 0 results were displayed for both SDVOSB(s) and VOSB(s). Another SBA search was conducted with 334510 and keyword “hemodialysis” was conducted and 0 SDVOSB(s) or VOSB(s) were displayed. A search on GSA Advantage was searched with keyword “hemodialysis monitor” and “Transonic HD03 Hemodialysis Monitoring” and no results were displayed. A market research survey was sent to OEM SB Transonic Systems and it was learned they are the sole manufacturer and distributor for the portable hemodialysis flow system as there are no other competitors in the marketplace at this time. A sole source letter was provided and is on file.
5. Contracting Officer's Certification: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
Manasés Cabrera Contracting Officer Date
MANASES CABRERA Digitally signed by MANASES CABRERA Date: 2026.03.20 07:33:02 -04'00'
File details come from the government source that posted it. Updated .