6515--NX EQ Recorders, Physiologic, pH, Upper Gastrointestinal Tract (VA-26-00040316)

DESCRIPTION

THIS IS NOTICE OF INTENT TO SOLE SOURCE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC) is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) as a means of conducting market research to identify qualified sources with the capability and the resources to meet the Veterans Health Administration s (VHA) Non-Expendable Equipment National Program requirement for Pachymeters: Corneal Ultrasound.

The SAC in conjunction with VHA is seeking a qualified source to provide Medtronic® Bravo Reflux Testing System to include service plan on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver the Medtronic® Bravo Reflux Testing System to include service plan to VA medical centers and facilities throughout the United States and its territories.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112- Surgical and Medical Instrument Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1000 employees.

The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM.gov prior to submitting an offer or quotation. You may access the website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of quote submission.

Submissions for this sources sought shall be submitted by email no later than February 13, 2026, 5:00 PM Eastern to all the following:

Kyle.franks@va.gov

Felicia.demita@va.gov

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Intent to Source Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time.

SCOPE

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Recorders, Physiologic, pH, Upper Gastrointestinal Tract product line as a candidate for a VA-wide (otherwise referred to as national ) contract for Recorders, Physiologic, pH, Upper Gastrointestinal Tract.

Electronic data storage recorders that include wireless transmitters, catheters (e.g., esophageal, biliary) and an electronic amplifier. There are two basic types of recorders: real time and retrospective, according to the point at which analysis is performed. These recorders are commonly used in ambulatory patients to correlate pH data (e.g., data related to gastroesophageal reflux) to patient symptoms.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Recorders, Physiologic, pH, Upper Gastrointestinal Tract to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.

The following Contract Line-Items Number (CLIN) are being considered:

Contract Line Items

Manufacturer

Part Number

Description

0001

Medtronic

FGS-0634

Bravo CF Reflux Recorder

0002

Medtronic

FGS-0306

Bravo Vacuum Pump (110V) Medela brand pump

0003

Medtronic

FGS-0309

Bravo Vacuum Pump Kit Includes silicone tubing with coupling, 180 cm tubing (no fingertip control), 0.25 L canister, and lid with overflow protection

0004

Medtronic

ASM-0550-01

Carry Case for BR2 Receiver Case only; straps sold separately USD 31.00

0005

Medtronic

FGS-0340

Bravo Vacuum Pump Tubes (10-pack) For Medela brand pump

0006

Medtronic

FGS-0493

Calibration Stand Bravo/Digitrapper Includes four 2793 tubes (250 mm x 18 mm)

0007

Medtronic

FGS-0687

Bravo Pump Virus Filters (10-pack)

0008

Medtronic

FGS-0516

Bravo pH Recorder Straps (5-pack)

0009

Medtronic

FGS-0656

Reflux Software v6.1 Includes 10 licenses: for use with Bravo Calibration-Free (CF)

0010

Medtronic

PSP-0023-LF

15W AC-DC Adaptor with Mini USB Plug

0011

Medtronic

PSP-0024-LF

Wall charger: plug adapter sold separately

0012

Medtronic

WIR-0075-LF

Interchangeable AC Plug Kit

0013

Medtronic

80263

Includes EU, UK, Australia, and US adapters

0014

Medtron

80264

USB 1.1 Cable (A Male to B Mini, 1 m) USB cable only

0015

Medtronic

80265

Reflux Recorder 1 Year Service Plan

0016

Medtronic

80268

Service Plan Reflux Recorder 1 Year, First Recorder

0017

Medtronic

80269

Reflux Recorder 2 Year Service Plan Service Plan Reflux Recorder 2 Year, First Recorder (Bravo or Digitrapper)

0018

Medtronic

80270

Reflux Recorder 3 Year Service Plan Service Plan Reflux Recorder 3 Year, First Recorder

The Department of Veterans Affairs (VA) is seeking vendors who can provide Medtronic® Bravo Calibration-Free Wireless Esophageal pH Monitoring System Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero.

CLIN s 0001-0018 apply to the following SC s:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

FDA Clearance 510K required

Literature Review

SC 2

Calibration-Free pH wireless Sensor Technology

Literature Review

SC 3

Extended 96-Hour recording capability or better

Literature Review

SC 4

Must be a wearable wireless external receiver capable of uninterrupted data collection

Literature Review

SC 5

Receivers shall allow patients to record symptoms, meals, and body position changes

Literature Review

SC 6

system shall include manufacturer-provided reflux analysis software specifically designed for use with the recorder

Literature Review

SC 7

Must include Service Plans for the repair, maintenance and updating of system and software

Literature Review

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Full name and address of company.

SAM Unique Entity Identifier (UEI).

Business Size.

Manufacturer or Distributor:

If distributor, provide full name, business size and address of manufacturer.

If distributor, provide evidence that your firm is an authorized distributor for the manufacturer of the products proposed.

Country of Origin designation for all products proposed.

Ability to provide uninterrupted supply of products on a national scale.

Technical Literature that clearly shows product(s) meets the identified salient characteristics and page numbers where each salient characteristic is met.

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

Vendor is requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

If distributor, provide full name, business size and address of manufacturer.

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Item pricing information of products, inclusive of flat rate shipping. Include any quantity discounts, noting at what level of quantity ordered should the Government expect tiered price reductions, if any.

NOTE: In order for the Contracting Officer to determine whether a set-aside can be pursued, it is essential to provide pricing information. Without this information, the Contracting Officer will be unable to assess whether there is a reasonable expectation of receiving fair and reasonable pricing from socio-economic concerns.

Does your firm have any subcontracting opportunities for this equipment?

Identify any federal contracts vehicles held by your firm that provides this equipment.

Are there any further standards or criteria VA should consider in a procurement action for this equipment?

Are the Government s specifications unduly restrictive?

Any additional information the Government should know prior to issuing a solicitation.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.