6515--clitoral therapy device (CTD)

NOTICE OF ACTION: This is a Sources Sought/Request for Information. The Department of Veterans Affairs (VA), Office of Acquisition Operations, Strategic Acquisition Center (SAC) is seeking potential vendors capable of providing an uninterrupted supply of Clitoral Therapy Device (CTD) and Accessories for In Home Use (see minimum technical requirements) under North American Industry Classification System (NAICS) code: 339113 Surgical Appliance and Supplies Manufacturing. This requirement is for a commercial off the shelf item. This is an enterprise strategic effort. MINIMUM TECHNICAL REQUIREMENTS The following are the Minimum Technical Requirements (MTRs) as identified by the Integrated Product Team (IPT) for CTDs. The MTRs are based on the clinical needs of impaired patient population receiving care in VA medical facilities The Device must be FDA approved. Battery-Operated Clitoral Therapy Device System hand-held for female sexual dysfunction. The CTD system shall include at a minimum the below components: Battery-operated, FDA approved device with a single hand dial and vacuum port 46 reusable silicone clitoral cups 2 Extenders a soft plastic tube that connects to the device and clitoral cup to increase control and use of the device AAA Batteries Water Soluble Gel Written instruction manual in both English and Spanish Access to video instructions Warranty: a standard commercial warranty on at least the battery-operated device for a minimum of one year. Toll Free number for Customer Support: the contractor shall provide a toll-free number to reach a live representative to assist with trouble shooting, use of the device, general customer service. This number shall be staffed a minimum of eight hours a day, Monday-Friday. Replacement Parts. The below components must be available for replacement as medically necessary for appropriate functioning. 21 reusable silicone clitoral cup packages 2-pack extender package INFORMATION REQUESTED: Interested parties should submit a capability statement that provides the following information: 1. Business Size: Type of Business of Prime Contractor (Check all applicable boxes) Large   Small (Check type of Small Business Below, if applicable)     Small Disadvantaged Business (SBA Certified)   Women-Owned Small Business   HUB Zone Small Business (SBA Certified)   Veteran Owned Small Business*     Serviced Disabled Veteran Owned Small Business*     8(a) Small Business (SBA Certified)   *If SDVOSB or VOSB indicate if your company is certified in VetBiz (vip.vetbiz.gov) repository. 2. Does your company maintain any Schedule Contracts (e.g., GSA, GWAC etc.)? If so, list where the required supplies are offered (please provide the contract number, expiration date, and Government point of contact). 3. Identify the type of Clitoral Therapy Device Kits offered (include Kit description). If you are a distributor, identify the manufactured devices authorized to supply. 4. Any current or historical contracts related to this requirement (enterprise wide): a. Contract Number b. Contract Type c. Total Contract Value d. Period of Performance e. Brief Project Requirement Description f. Prime or subcontractor RESPOINSES: Responses are due via email to Contract Specialist John Tarver John.Tarver@va.gov by 4:30 PM Eastern Standard Time (EST) February 16, 2024. Do not compress (zip) RFI responses. VA Network Security Operations Center (NSOC) has temporarily blocked email attachments with the .zip extension as a mitigation measure against the ongoing world-wide ransomware event impacting many organizations. During this time, .zip file extensions will be permanently stripped from email traffic and will not be recoverable. DISCLAIMER: This Source Sought/RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Source/Sought RFI. Therefore, the Government recommends vendors submit electronic versions of documentation, white papers, and other relevant information. The Government is not obligated to provide comments to vendor submissions.