6515--596-24-3-950-0242 - HALOFLEX GENERATOR

Special Notice Special Notice Special Notice *= Required Field Special Notice Intent to Sole Source - Covidien Sales LLC SPECIAL NOTICE: 36C24924Q0132 The Department of Veterans Affairs intends to issue a sole-source firm-fixed priced contract to Covidien Sales LLC, 3555 Koger Boulevard Suite 200, Duluth, GA 30096. In accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i) and on behalf of the Lexington Veterans Affairs Medical Center (VAMC), GI Clinic, Network Contracting Office (NCO) 9 intends to issue an open market sole source firm-fixed priced contract to Covidien Sales LLC, 3555 Koger Boulevard Suite 200, Duluth, GA 30096. The rationale for the sole source acquisition is that Covidien Sales LLC (Large Business), a Medtronic company, is the sole manufacturer of its proprietary Barrx ablation system, associated parts, accessories, and applicable licensed software applications. The Barrx ablation system is a radio-frequency ablation system used to treat Barrett s esophagus (BE) patients by eradicating Barrett s epithelium. The system is used for the coagulation of soft tissue in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. Its use includes, but not limited to, the esophagus, esophagus ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomate, Barrett s esophagus, Dieulafoy s lesions, and angiodysplasia. The system includes a RFA energy generator and a family of ablation catheters, which are designed to precisely control depth and uniformity of GI tissue ablation. It provides the flexibility to choose either large catheter for larger treatment areas or small catheters for smaller focal areas. Covidien Sales LLC sells directly to the end user facilities and as such, there are no agents or dealers authorized to represent this product. The North American Industry Classification System (NAICS) for this requirement is, 334510 - Product of Service Code for this requirement is 6515. The Small Business Administration (SBA) size standard for this sector is 1,250 employees. Background. The Lexington Veterans Affairs Medical Center (VAMC), GI Clinic, 1101 Veterans Drive, Lexington, KY 40502, has a requirement to replace a Haloflex Energy Generator X1 system, which has passed its serviceable life. Delivery must be FOB destination 90 days after receipt of order. ITEM INFORMATION MFR # ITEM DESCRIPTION QTY 1190A-115A HALOFLEX ENERGY GENERATOR X1 1 CART-100 HALO CART X1 1 FLEXCC - 020A HALOFLEX OUTPUT CABLE X1 1 FLEXFS - 010A HALOFLEX FOOTSWITCH X1 1 Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. Capability statement /information sought: Response to this announcement shall not to exceed 10 pages and should include the following information: (1) A tailored capability statement indicating the firm s ability to provide a product and related services; (2) The respondents DUNS number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc,) pursuant to the applicable NAICS code; (3) Information should be provided electronically in a Microsoft Word or Adobe PDF format. This notice of intent is not a request for competitive quotes. However, interested parties may identify their interest and capability to respond to the requirement and submit capability statement no later than 10:00 am., CT, Monday, August 19, 2024, to: larry.olive@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government. If no written response is received within the closing date of this notice, a sole source award will be made to Covidien Sales LLC without any further notice. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. 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. However, responses to this notice will not be considered adequate responses to a notice.