SAM #36C10X26Q0087

VA Sole Source Procurement of Medtronic Bravo Reflux Testing System Recorders and Accessories

The Department of Veterans Affairs (VA), through its Strategic Acquisition Center (SAC) Frederick, is seeking to procure Medtronic Bravo Reflux Testing System Recorders and related accessories and service plans for nationwide use in VA medical centers. - Government Buyer: - Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Strategic Acquisition Center (SAC) Frederick - OEM Highlight: - Medtronic Inc. is the sole Original Equipment Manufacturer (OEM) specified for all products and services - Products and Quantities: - Bravo CF Reflux Recorders (FGS-0634): estimated 20 units per year - Bravo Vacuum Pumps (FGS-0306), Vacuum Pump Kits (FGS-0309), Carry Cases (ASM-0550-01), Vacuum Pump Tubes (FGS-0340), Calibration Stands (FGS-0493), Pump Virus Filters (FGS-0687), pH Recorder Straps (FGS-0516), Reflux Software v6.1 (FGS-0656, 10 licenses per set), AC-DC Adaptors (PSP-0023-LF), Wall Chargers (PSP-0024-LF), Interchangeable AC Plug Kits (WIR-0075-LF), Adapter Kits (80263), USB Cables (80264) - Service Plans for Reflux Recorders: 1, 2, and 3-year options (part numbers 80265, 80268, 80269, 80270), for both first and additional recorders, estimated 20 per year - Notable Requirements: - Only new, FDA 510K-cleared Medtronic Bravo equipment is acceptable - Calibration-free, wireless sensor technology for upper GI pH monitoring - Extended recording capability and wearable, wireless receivers - Manufacturer-provided reflux analysis software and service plans for repair, maintenance, and software updates - Nationwide delivery to VA medical centers and facilities - All equipment must include manufacturer warranties - Period of Performance: - 12-month base period with four 12-month option years (potential total of five years) - Place of Performance and Delivery: - Nationwide delivery to VA facilities - Contracting office: SAC Frederick, 5202 Presidents Court, Suite 103, Frederick, MD 21703

Description

NOTICE OF THE INTENT TO SOLE SOURCE:

THIS IS A NOTICE OF INTENT TO SOLE SOURCE. This notice is prepared in accordance with Federal Acquisition Regulation (FAR) 5.101 Pre-solicitation Notice. This announcement constitutes the only notice and synopsis of the proposed action.

The Department of Veterans Affairs (VA), Strategic Acquisition Center (SAC), on behalf of the Veterans Health Administration (VHA), Equipment Life Cycle Management (ELCM) Program intends to award Firm Fixed Price (FFP) sole source award for the procurement of Medtronic Bravo Relfux Testing System Recorder: Recorders, Physiologic, pH, Upper Gastrointestinal Tract and associated service plans with Medtronic INC, 710 Medtronic PKWY, Minneapolis, MN 55432.

The applicable North American Industrial Classification System (NAICS) code 339112 Surgical and Medical Instrument Manufacturing is most appropriate for this requirement. The size standard is 1,000 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. 1901, as implemented by the Federal Acquisition Regulation (FAR) 12.102(b). Interested parties may identify their interest and capability to respond to this requirement. Supporting information must be furnished in sufficient detail to demonstrate the ability to comply with the requirements. Telephone requests will not be honored. Submissions for this notice shall be submitted by email no later than May 28, 2026, 5:00 PM Eastern to all the following:

Kyle.franks@va.gov Felicia.demita@va.gov

Responses received will be reviewed; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. No cost to the government will arise as a result of contractor submissions of responses to this announcement or the government use of such information.

Contract Line-Item Numbers (CLIN):

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 Medtronic 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 following details are applicable salient characteristics: CLIN 0001 - 0018 applies to SC 1-7 for Medtronic Bravo Relfux Testing System Recorder: Recorders, Physiologic, pH, Upper Gastrointestinal Tract:

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

THIS IS NOT A REQUEST FOR QUOTATION/PROPOSAL. THE GOVERNMENT IS NOT RESPONSIBLE FOR ANY COSTS ASSOCIATED WITH RESPONDING TO THIS NOTICE.

Additional Links:VA | OALC | OPAL | SAC

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