SAM #36C24426Q0832

VA Lebanon Medical Center Seeks FDA-Cleared CO2 Insufflator System for CT Colonography

The Department of Veterans Affairs, Network Contracting Office 4, is seeking an FDA-cleared CO2 insufflator system for the Lebanon VA Medical Center to support CT colonography procedures. - Government Buyer: - Department of Veterans Affairs - Network Contracting Office 4 - Lebanon VA Medical Center - Products/Services Requested: - FDA-cleared CO2 insufflator for CT colonography - Must have active 510(k) premarket clearance under FDA regulation 21 CFR 876.1500 (Endoscopy and Accessories) - Automated, software-controlled CO2 delivery system - Built-in pressure relief and one-touch intracolonic pressure venting - Integrated effluent collection container and hydrophobic filter - Monitoring and recording of CO2 insufflation - Fully automated low-pressure CO2 insufflation - CO2 supply cylinder gauge - LCD display with ready-to-scan features - Auto over-insufflation alerts, visual displays for pressure and volume, and safety shutdown features - Accessory cart for the insufflator - On-site installation and training at the medical center - One-year manufacturer warranty - Unique/Notable Requirements: - Equipment must be FDA-cleared specifically for CT colonography - Vendors must provide a Letter of Authorization from the OEM and product literature - Procurement is restricted to small businesses, with preference for veteran-owned and service-disabled veteran-owned small businesses - No specific OEMs or part numbers are mentioned; vendors may propose any qualifying FDA-cleared solution

Description

Sources Sought Notice

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: _____________________

1. 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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