36C10X26R0063 Intent to Sole Source_NX EQ Hemodialfiltration Units.pdf

Presolicitation Notice

*=Required Field Presolicitation Notice

SUBJECT* NX EQ Hemodiafiltration Units

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 21703

SOLICITATION NUMBER* 36C10X26R0063

RESPONSE DATE/TIME/ZONE 09-18-2026 12:00 EASTERN TIME, NEW YORK,

USA

ARCHIVE 45 DAYS AFTER THE RESPONSE DATE

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

PLACE OF PERFORMANCE Nationwide

POSTAL CODE

COUNTRY

CONTACT INFORMATION

CONTRACTING OFFICE ADDRESS Enterprise Procurement Office (EPO)

Department of Veterans Affairs

5202 Presidents Court, Suite 103

Frederick MD 21703

POINT OF CONTACT*

Contract Specialist

Levi Russin

Levi.Russin@va.gov

Contracting Officer

Jessica Smith

Jessica.Smith32@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This Notice of Intent to Sole Source is not a request for competitive quotations or proposals.

The Department of Veterans Affairs intends to negotiate and award a firm-fixed-price sole-source Requirements contract, in accordance with FAR 6.103-1(b), to a Large Business for the brand name Fresenius 5008XTM CAREsystem Hemodiafiltration Units and associated accessories.

The applicable North American Industry Classification System (NAICS) code is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing, with a small business size standard of 1,250 employees. The Product Service Code (PSC) is 6515, Medical and Surgical Instruments, Equipment, and Supplies.

The statutory authority permitting other than full and open competition is 41 U.S.C. § 3304(a)(1), as implemented by FAR 6.103-1(b), “Authorized or required by statute.”.

Interested parties may identify their interest and capability to meet this requirement. Any response must include sufficient detail to demonstrate the ability to provide all line items described below. No solicitation is available, and telephone requests will not be accepted.

Responses received will be considered; however, the Government’s decision whether to compete this requirement based on responses to this notice remains solely within the Government’s discretion. The Government will not reimburse any costs incurred by contractors in responding to this notice, nor for the Government’s use of any information received.

Requirement Description

Hemodiafiltration Units are extracorporeal blood purification units used in renal replacement therapy and designed to combine diffusion and convection to remove uremic toxins, excess electrolytes, and fluid from blood. The unit operates by withdrawing blood from the patient through a vascular access line and circulating it through a dialyzer containing a semi-permeable membrane; small solutes diffuse across the membrane into a countercurrent flow of dialysate, while larger molecular weight substances are removed via convective transport driven by transmembrane pressure, with a controlled volume of plasma water filtered and replaced by sterile substitution fluid. Core components include a blood pump that regulates extracorporeal blood flow, a dialyzer (filter cartridge) that facilitates solute exchange and ultrafiltration, a dialysate delivery system that prepares and circulates electrolyte-balanced fluid, a substitution fluid system that infuses replacement fluid either pre- or post-filter, pressure monitors and sensors, air detectors and venous clamps, anticoagulation systems to prevent clotting within the circuit, and a central control unit with software that coordinates flow rates, pressures, fluid balance, and treatment parameters.

Contract Line Item Numbers (CLIN)

CLIN Manufacturer Part Number Description

Fresenius USA, Inc.

M204441

5008X CAREsystem + CLiC + CDX (Includes: 5008X Hemodialysis Machine (w/ bibag module, Crit-Line Clip (CLiC), Clinical Data Exchange (CDX)), Two (2) DIASAFE®plusUS Filters (MPN F00007039), One (1) year warranty, and installation and initial clinician training.)

Fresenius USA, Inc.

M362301 Blood Temperature Monitor

Fresenius USA, Inc.

F50043326 Keyboard with Swivel Arm

Fresenius USA, Inc.

F50044946 Support Plate

Fresenius USA, Inc.

F50044948 Top Tray

Fresenius USA, Inc.

F50044953 Acid Connector Guide (1 Gal)

Fresenius USA, Inc.

F50044950 Acid Connector Guide (10L Jug)

Fresenius USA, Inc.

F50035686

Insulated Water Inlet Tube Kit (Includes: Hose and Connector)

Fresenius USA, Inc.

M422351 Retro Kit Permeate Connector

Fresenius USA, Inc.

F00012969 FX CorAL 60 HD/HDF Dialyzers (Qty 24)

Fresenius USA, Inc.

F00012970 FX CorAL 80 HD/HDF Dialyzers (Qty 24)

Fresenius USA, Inc.

F00012971 FX CorAL 100 HD/HDF Dialyzers (Qty 24)

Fresenius USA, Inc.

F00012972 FX CorAL 120 HD/HDF Dialyzers (Qty 24)

Fresenius USA, Inc.

03-5300-3 5008X HD/HDF Standard Blood Tubing Set (Qty 24)

Fresenius USA, Inc.

03-5300-3C 5008X HD/HDF with CLiC Blood Tubing Set (Qty 24)

Fresenius USA, Inc.

03-5350-8 5008X HD/HDF with Twister Blood Tubing Set (Qty 24)

Fresenius USA, Inc.

03-5110-6 Pre-Flush, HD Standard Bloodline (Qty 24)

Fresenius USA, Inc.

03-5160-1 Pre-Flush, HD Twister Bloodline (Qty 24)

Fresenius USA, Inc.

04-3000-9 5008X HD/HDF Medication Line (Qty 100)

Fresenius USA, Inc.

04-9310-6

5008X Venous Pressure Replacement Line with Transducer (Qty 80)

Fresenius USA, Inc.

04-9009-4 Fluid Sampling Accessory 5008X (Qty 15)

Fresenius USA, Inc.

28-0600-1 CitraSure Disinfectant (Qty 2)

Fresenius USA, Inc.

CAREkit-1

FX CorAL 60 HD/HDF Dialyzer Kit (Includes: MPN F00012969 and MPN 03-5300-3 (Standard))

Fresenius USA, Inc.

CAREkit-2

FX CorAL 80 HD/HDF Dialyzer Kit (Includes: MPN F00012970 and MPN 03-5300-3 (Standard))

Fresenius USA, Inc.

CAREkit-3

FX CorAL 100 HD/HDF Dialyzer Kit (Includes: MPN F00012971 and MPN 03-5300-3 (Standard))

Fresenius USA, Inc.

CAREkit-4

FX CorAL 120 HD/HDF Dialyzer Kit (Includes: MPN F00012972 and MPN 03-5300-3 (Standard))

Fresenius USA, Inc.

CAREkit-5

FX CorAL 60 HD/HDF Dialyzer Kit (Includes: MPN F00012969 and MPN 03-5300-3C (CLiC))

Fresenius USA, Inc.

CAREkit-6

FX CorAL 80 HD/HDF Dialyzer Kit (Includes: MPN F00012970 and MPN 03-5300-3C (CLiC))

Fresenius USA, Inc.

CAREkit-7

FX CorAL 100 HD/HDF Dialyzer Kit (Includes: MPN F00012971 and MPN 03-5300-3C (CLiC))

Fresenius USA, Inc.

CAREkit-8

FX CorAL 120 HD/HDF Dialyzer Kit (Includes: MPN F00012972 and MPN 03-5300-3C (CLiC))

Fresenius USA, Inc.

CAREkit-9

FX CorAL 60 Kit HD/HDF Dialyzer (Includes: MPN F00012969 and MPN 03-5350-8 (Twister))

Fresenius USA, Inc.

CAREkit-10

FX CorAL 80 Kit HD/HDF Dialyzer (Includes: MPN F00012970 and MPN 03-5350-8 (Twister))

Fresenius USA, Inc.

CAREkit-11

FX CorAL 100 Kit HD/HDF Dialyzer (Includes: MPN F00012971 and MPN 03-5350-8 (Twister))

Fresenius USA, Inc.

CAREkit-12

FX CorAL 120 Kit HD/HDF Dialyzer (Includes: MPN F00012972 and MPN 03-5350-8 (Twister))

Fresenius USA, Inc.

F00007039 DIASAFEplus Filters (Qty 10)

Fresenius USA, Inc.

M358781 Cover for DIASAFEplus Filter (2x)

Fresenius USA, Inc.

36-7005-0 Accumix Dry Acid Dissolution System, Single Phase Pump

Fresenius USA, Inc.

36-7050-0 Accumix Dry Acid Dissolution System, Three Phase Pump

Fresenius USA, Inc.

150289I Installation for Accumix Tank

Fresenius USA, Inc.

08-1251-CA

Citrasate Liquid Acid Concentrate Bottle 1K, 2.5Ca, 1Mg (Qty 4)

Fresenius USA, Inc.

0FD2201-3B

GranuFlo Dry Acid Concentrate Bag 2K, 2.0Ca, 1Mg (Qty 3)

Fresenius USA, Inc.

0FD2251-3B

GranuFlo Dry Acid Concentrate Bag 2K, 2.5Ca, 1Mg (Qty 3)

Fresenius USA, Inc.

0FD3251-3B

GranuFlo Dry Acid Concentrate Bag 3K, 2.5Ca, 1Mg (Qty 3)

Fresenius USA, Inc.

0FD2251-DA

Citrasate DRY—Dry Acid Concentrate Bag 2K, 2.5Ca, 1Mg (Qty 4)

Fresenius USA, Inc.

0FD3251-DA

Citrasate DRY—Dry Acid Concentrate Bag 3K, 2.5Ca, 1Mg (Qty 4)

Fresenius USA, Inc.

13-2201-5

NaturaLyte Liquid Acid Concentrate, 2K, 2.0Ca, 1Mg, 55 Gallon

Fresenius USA, Inc.

13-2251-0

NaturaLyte Liquid Acid Concentrate, 2K, 2.5Ca, 1Mg, 55 Gallon

Fresenius USA, Inc.

13-3251-9

NaturaLyte Liquid Acid Concentrate, 3K, 2.5Ca, 1Mg, 55 Gallon

Fresenius USA, Inc.

08-67753-0 Sterilyte Liquid Sodium Bicarbonate, Bottle (Qty 4)

Fresenius USA, Inc.

282100 Saline, 0.9%, 1000 mL (Qty 12)

Fresenius USA, Inc.

04-9300-7 Prime Bag (Qty 100)

Fresenius USA, Inc.

04-9006-5

Priming Set for Arterial Bloodlines, with Needleless Access Port., EtO Sterilized (Qty 100)

Fresenius USA, Inc.

04-9502-8

Bloodline, Recirculation Connector, Individually Wrapped, Sterile (Qty 200)

Fresenius USA, Inc.

35-8181-6

Bloodline, Recirculation Connector, Individually Wrapped, Sterile (Qty 100)

Fresenius USA, Inc.

M8-5007

Bloodline, MEDIC Plastic Antistick Needle, Sterile (Qty 1,000)

Fresenius USA, Inc.

5726271 Protection Cap, 5.5 x 12.7, Black

Fresenius USA, Inc.

6400651 Canister Screw Cap, Red

Fresenius USA, Inc.

6526131 Suction Tube Filter

Fresenius USA, Inc.

6767001 Label "HOT RINSE" (Qty 10)

Fresenius USA, Inc.

191338 Bottle 1L

Fresenius USA, Inc.

F40017049 BPM Cuff 13-17cm, Extra Small (XS)

Fresenius USA, Inc.

F40017050 BPM Cuff 17-24cm, Small (S)

Fresenius USA, Inc.

F40017051 BPM Cuff 24-34cm, Medium (M)

Fresenius USA, Inc.

F40017052 BPM Cuff 34-50cm, Large (L)

Fresenius USA, Inc.

F40017053 BPM Cuff 50-70cm, Extra Large (XL)

Fresenius USA, Inc.

F50020690 BPM Tube

Fresenius USA, Inc.

F50034818 Holder, Blood Pressure Cuff w/ Pressure Connection

Fresenius USA, Inc.

F40017675 Hose Water Inlet

Fresenius USA, Inc.

F40019628 Cannister Connector 1L Disinfectant Bottle

Fresenius USA, Inc.

F50004506 Suction Tube with Filter, Short

Fresenius USA, Inc.

F50004507 Suction Tube with Filter, Long

Fresenius USA, Inc.

F50011269 Inlet Connector

Fresenius USA, Inc.

F50014559 Concentrate Plug, Red (2x) (incl. tube red 3.5m)

Fresenius USA, Inc.

F50031006 Water Inlet Tube Reinforcement

Fresenius USA, Inc.

F50036572 Coupling

Fresenius USA, Inc.

F50036587 Installation Kit Water Inlet Tube

Fresenius USA, Inc.

F50036593 Wrench (CitraSure)

Fresenius USA, Inc.

F50036594 1 L Disinfectant Bottle w/ Label

Fresenius USA, Inc.

M405071 Bayonet Joint, Water Inlet, Non-Fresenius RO Systems

Fresenius USA, Inc.

M347031 Bayonet Joint, Central Acid Delivery

Fresenius USA, Inc.

M541761 Bayonet Joint, Central Delivery System (CDS)

Fresenius USA, Inc.

M347041 Bayonet Joint Water Inlet

Fresenius USA, Inc.

F50043866 Bayonet Joint Disinfection

Fresenius USA, Inc.

M324561 Grip Handle, Red

Fresenius USA, Inc.

M324581 Grip Handle, Blue

Fresenius USA, Inc.

M349981 Tension Belt with Velcro Fastener

Fresenius USA, Inc.

M359451 Tube Holder

Fresenius USA, Inc.

M371001 Concentrate Suction Tube, Red

Fresenius USA, Inc.

M371011 Bicarbonate Suction Tube, Blue

Fresenius USA, Inc.

M381131 Hose Clip D18.5, Stainless

Fresenius USA, Inc.

M384061 Drain Tube, Silicone, Black

Fresenius USA, Inc.

M385111 Inlet Tube, Silicone, Black

Fresenius USA, Inc.

M389281 Set of Tube Markers, CDS (Qty 4)

Fresenius USA, Inc.

M392621 Set of Caps (Qty 72)

Fresenius USA, Inc.

M409501 Set of Tube Fasteners (Qty 4)

Fresenius USA, Inc.

M444551 PVC-Tube, Red, 5 x 3mm, 3M Long, CDS

Fresenius USA, Inc.

M444571 PVC-Tube, Blue, 5 x 3mm, 3M Long, CDS

Fresenius USA, Inc.

M395061 Water Inlet Filter

Fresenius USA, Inc.

M403421 Tube Holder, Self-Adhesive

Fresenius USA, Inc.

M418491 Key 1L Disinfectant Bottle

Fresenius USA, Inc.

M439451 Inlet Tube, Insulated 6 x 2.95mm

Fresenius USA, Inc.

M489801 Media Connecting Profile

Fresenius USA, Inc.

M520271 Disinfectant Tube, 6.2 x 3, 3M Long

Fresenius USA, Inc.

24-AAMI-0

AAMI Water Profile Kit (Includes: Full panel water test - AAMI, NTL, and particle analysis)

Fresenius USA, Inc.

24-AAMI-1

Microbiological Profile Kit (Includes: CFU culture testing for bacteria and LAL endotoxin testing for dialysis water quality assessment)

Fresenius USA, Inc.

100013

5008X Formal Training Fee, Individual Technician Training (non-credit student) - Level 1 (Dallas, TX location.

Technician responsible for own travel expenses.)

Fresenius USA, Inc.

100013A

5008X Formal Training Fee, Individual System Technician Training (non-credit student) - Level 2 (Dallas, TX location. Technician responsible for own travel expenses.)

Fresenius USA, Inc.

100013B

5008X Formal Training Fee, Individual Technician Training (non-credit student) - Level 1 (Louisville, KY location.

Technician responsible for own travel expenses)

Fresenius USA, Inc.

100013C

5008X Formal Training Fee, Individual Technician System Training (non-credit student) - Level 2 (Louisville, KY location. Technician responsible for own travel expenses)

Fresenius USA, Inc.

F020403

Two (2) Year Service Agreement. (Includes: All Biennial (every two years) Preventative Maintenance (PM) services, all repairs (parts and labor), and all travel expenses. Does not include Diasafe Plus changes, microbial sampling or abuse. A formalized service contract per facility is required.)