SPECIAL NOTICE
65 -- Notice of Intent to Sole Source
- Notice Date
- 7/16/2013
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264513RCES076
- Archive Date
- 9/30/2013
- Point of Contact
- Brian D. Miller, Phone: 3016191086
- E-Mail Address
-
brian.miller4@med.navy.mil
(brian.miller4@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Boston Scientific, 100 Boston Scientific Way, Marlborough, MA 01752. Naval Medical Center San Diego (NMCSD) has a need for one bronchial tissue ablation radiofrequency therapy system. The system shall be capable of providing bronchial thermoplasty. The system shall be able to deliver controlled thermal radiofrequency energy directly to the patient's airway wall to reduce the amount of smooth muscle. The system shall have a controller unit that generates and controls the energy. The system shall also have a catheter that is able to deliver the energy from the controller to the airway wall. The catheter shall be able to be delivered to the desired site through a standard bronchoscope through the patient's nose or mouth. The system shall have a safety mechanism to shut off the radiofrequency controller. The system and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment and reagents shall be compliance with OSHA requirements. 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. Upon delivery, the vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor shall make arrangements for the storage. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. 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 Brian Miller at brian.miller4@med.navy.mil. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller. Email challenges are preferred. Closing date for challenges is no later than 10:00 AM. ET on 1 August 2013. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264513RCES076/listing.html)
- Place of Performance
- Address: Naval Medical Center San Diego (NMCSD), San Diego, California, United States
- Record
- SN03118477-W 20130718/130716235940-537258b92b16e2c2317ae866a55476f1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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