Inactive
Notice ID:N62645-19-Q-0009
The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.106-1(b)(1)). The proposed source is Medtronic, Inc. of 161 Cheshire Lane Suite 100, Plymouth, M...
The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.106-1(b)(1)). The proposed source is Medtronic, Inc. of 161 Cheshire Lane Suite 100, Plymouth, MN 55441. The Naval Medical Logistics Command has a requirement for two (2) Radiofrequency (RF) Therapy Systems, Vein Occlusion for Naval Medical Center (NMC) Portsmouth. The units shall be FDA-approved for endovenous ablation, utilizing radiofrequency (RF) as the operative technology. The units shall have an FDA indication to treat the entire superficial venous system, including the great saphenous vein (GSV), small saphenous vein (SSV), and perforator veins (PV). The units shall use at least a 7 cm long RF heating element. The units shall include a touchscreen display for treatment parameters. The units shall include audible alert tones that indicate device functions. The power requirements are 120 VAC, 60 Hz. Medtronic is the only vendor that can provide a vein occlusion radiofrequency therapy systems that has an FDA indication for treatment of perforator veins. Additionally Medtronic is the only vendor that can provide a unit that is able to treat the entire superficial venous system (GSV, SSV, PV). No other vendor can provide a unit with an FDA indication for treatment of the entire superficial venous system. Thus, Medtronic is the only vendor that meets the minimum requirements of the Government. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The system, including claims made for the product, shall be compliant with FDA regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements. This acquisition is being conducted under simplified acquisition procedures (IAW FAR 13.106-1(b)(1)). There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 1000 employees. This notice of intent is not a request for competitive proposals; however, if a vendor challenges the basis of this requirement, please email challenges and product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Josh Blickenstaff at joshua.g.blickenstaff.civ@mail.mil, reference solicitation number N62645-19-Q-0009. Closing date for challenges is no later than 1300 Local Time, 04 January 2019. No phone calls will be accepted. Please note that a determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
