Inactive Total Small Business Set-Aside (FAR 19.5)

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (FAR 13.106-1(b)(1)), soliciting from a single source. The proposed source is O.R. Elder Inc. of 1270 Broadway St... The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (FAR 13.106-1(b)(1)), soliciting from a single source. The proposed source is O.R. Elder Inc. of 1270 Broadway Ste 401, New York, NY, 10001-3218. United States Naval Hospital (USNH) Yokosuka has a requirement for one (1) phacoemulsification cataract extraction unit [17-596]. The unit shall be capable of performing phacoemulsification cataract surgery, including diathermy and anterior vitrectomy. The unit shall be capable of cortex removal. The unit shall be capable of torsional phacoemulsification. The unit shall allow for setting and maintaining a target intraocular pressure. The unit shall allow for continuous irrigation. The unit shall use peristaltic pumps to maintain a maximum vacuum pressure of at least 500 mmHg. The unit shall include a footswitch. The unit shall be capable of customizable surgeon-specific settings. The unit shall include eight (8) handpieces, of which four (4) shall include built-in fluidics pressure sensors. The power requirements are 110 VAC, 60 Hz. The vendor shall provide operator training for six (6) personnel. The vendor shall provide biomedical technician training for two (2) service personnel. The vendor shall provide two (2) operator manuals and two (2) service manuals in English. The system, including claims made for the product, shall be compliant with Food and Drug Administration (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. Contractor 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. Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339115. This notice of intent is not a request for competitive proposals. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on 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. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Mrs. Gerrie Johnson at gerrie.m.johnson.civ@mail.mil . Closing date for challenges is no later than 11:00 AM ET on 30 March 2021. No phone calls will be accepted.