SPECIAL NOTICE
65 -- RADIOFREQUENCY VEIN OCCLUSION THERAPY SYSTEM
- Notice Date
- 7/25/2013
- 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
- N0020313RCSU011
- 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 Covidien Sales, LLC of 15 Hampshire St., Mansfield, MA 02048. Naval Hospital Pensacola has a requirement for a radiofrequency vein occlusion therapy system. The unit shall treat diseased veins through emission of radiofrequency energy via a catheter. The unit shall allow for radiofrequency ablation that is controlled and repeatable. The unit shall be minimally invasive. The unit shall include a FDA approved radiofrequency generator and be compatible with catheters for endovascular coagulation of blood vessels. The catheters shall deliver uniform heat to the target areas. The unit shall include a tumescent pump to distribute local anesthetic to the treatment area. The unit shall come with onsite training. The electrical requirements are 110VAC and 60Hz. The system 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 system shall be installed in 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, Reference solicitation number N0020313RCSU011. Email challenges are preferred. Closing date for challenges is no later than 2:00 PM. ET on 9 August 2013. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N0020313RCSU011/listing.html)
- Place of Performance
- Address: Naval Hospital Pensacola, Florida, United States
- Record
- SN03128185-W 20130727/130726000526-96e91546d55c892f27dc7be17df55670 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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