6515--Insufflator
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Lebanon VA Medical Center is seeking qualified suppliers for an FDA-cleared, automated carbon dioxide insufflator specifically designed for use during CT colonography procedures, as required under 21 CFR 876.1500. The device must have an active 510(k) clearance, feature built-in pressure relief with one-touch venting, include an integrated effluent collection container and hydrophobic filter, and provide continuous monitoring and recording of CO2 insufflation throughout the procedure. It must offer fully automated low-pressure CO2 delivery, a cylinder pressure gauge, visual real-time displays of pressure and volume, auto over-insufflation alerts, and safety shutdown features. The system must be ready to scan with a clear LCD interface and be installed and trained on-site by the vendor. All equipment must come with a full manufacturer warranty for one year from installation verification. Interested parties must be registered in SAM.gov and respond with comprehensive company information including Unique Entity ID, CAGE Code, tax ID, and point of contact details. Responses must confirm socio-economic status under NAICS 339112, addressing eligibility as a small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone, woman-owned, or large business, and must indicate any GSA/FSS schedule number and expiration date. Products must be manufactured in accordance with U.S. regulations and include a capability statement, product literature, and OEM letter of authorization. All submissions are due by 11:00 a.m. EST on July 31, 2026, and must be emailed exclusively to Ryan Hatfield at Ryan.Hatfield@va.gov; no phone inquiries are permitted. The equipment will be shipped to the Lebanon VA Medical Center warehouse at 1700 S. Lincoln Ave., Lebanon, PA 17042.
General Info
Agency
NAICS
Place of Performance
Lebanon VAMC, Lebanon, PA, 17042Set-Aside
Documents
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Timeline
Response Deadline
Organization & Contact Information
Full Description
Sources Sought Notice
Page 5 of 5 Sources Sought Notice *= Required Field Sources Sought Notice
Page 1 of 4 Page 1 of 2 The Lebanon VAMC requires an insufflator meeting the following requirements:
Salient Characteristics
Must be FDA cleared for use within the VA for use during Computerized Tomography (CT) Colonography under FDA regulation 21 CFR 876.1500 (Endoscopy and Accessories) Must have an active 510(k) premarket clearance to be safely operated within VA medical Centers VA standards require an automated software-controlled carbon dioxide (CO2) delivery system rather than manual room air. FDA requirement: Class II insufflators must contain built-in pressure relief mechanisms Mechanism for intracolonic pressure venting one touch pressure venting Includes an integrated effluent collection container and hydrophobic filter Monitor and record C02 insufflation throughout the procedure Fully automated low pressure C02 insufflation capabilities CO2 supply cylinder gage to measure pressure during the procedure Ready to scan features on the LCD display Auto over-insufflation alerts Visual displays for pressure and volume throughout the procedure Safety shut down features
Accessories: Accessory Cart
Installation and Training: On-site vendor installation and training is required and shall be coordinated with the POC. Warranty of Equipment: Contractor must provide manufacturer warranty on all provided equipment and supplies for first year from date of receipt and verification of installation/operation. ALL ITEMS TO BE SHIPPED TO THE FOLLOWING LOCATION: Lebanon VA Medical Center (Attn: Warehouse), 1700S. Lincoln Ave., Lebanon, PA 17042. ALL INTERESTED PARTIES MUST ALSO HAVE AN ACTIVE REGISTRATION IN THE SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE. TO REGISTER, PLEASE VISIT WWW.SAM.GOV. Responses to this Sources Sought shall include:
Company Name
Address
Point of Contact
Phone Number
Email Address
Unique Entity ID
CAGE Code
Tax ID Number
In accordance with 38 U.S.C. 8127(d), a contracting officer of the Department shall award contracts on the basis of competition restricted to small business concerns owned and controlled by Veterans, if the contracting officer has a reasonable expectation that two or more small business concerns owned and controlled by veterans will submit offers, and that the award can be made at a fair and reasonable price that offers the best value to the United States. For purposes of this VA specific rule, a service-disabled veteran-owned small business (SDVOSB) or a veteran-owned small business (VOSB), must meet the eligibility requirements in 38 U.S.C. 8127(e), (f) and VAAR subpart 819.7003 and be listed as verified by the Small Business Administration at https://veterans.certify.sba.gov. Please provide answers to all questions below regarding your firm s Socio-Economic status pursuant to North American Industrial Classification Code (NAICS) 339112.
1. Is your business a small business under NAICS 339112? YES ______ NO ______
2. Is your firm a Veteran-Owned Small Business? YES ______ NO ______
3. Is your firm a Service-Disabled Veteran-Owned Small Business? YES ______ NO ______
4. Is you firm a certified HUB Zone firm? YES ______ NO ______
5. Is your firm a Woman Owned business? YES ______ NO ______
6. Is your firm a Large Business? YES ______ NO ______
7. What is your GSA/FSS schedule for these items? YES______ NO______
Schedule Number: ___________________
Expiration Date: _____________________
8. Where are the products manufactured? ______________________________
Please provide a capability statement as well as any relevant literature addressing your organization s ability to supply the required items. Also, please include a point of contact name, phone number, and email address. Note: Questions regarding this notice should be addressed to Ryan Hatfield via email only. NO PHONE CALLS WILL BE ACCEPTED REGARDING THIS REQUIREMENT. Please submit all responses to this notice via e-mail to: Ryan Hatfield Contract Specialist Ryan.Hatfield@va.gov Responses to this Sources Sought Notice are required by no later than Friday, July 31, 2026, at 11:00 am (1100) EST. If you are interested in submitting a response to this posting, please ensure to submit a Letter of Authorization from the OEM and a brochure/specification sheet for the product.
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