SPECIAL NOTICE
65 -- Notice of Intent to Sole Source to COvidien Sales LLC for Tissue Ablation Radiofrequency Therapy System
- Notice Date
- 5/21/2014
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264514RCES055
- Archive Date
- 6/21/2014
- Point of Contact
- Christina Boyd-Brown, Phone: 301-619-2059, Tameka N Davis, Phone: 301-619-1677
- E-Mail Address
-
christina.boyd-brown@med.navy.mil, tameka.davis@med.navy.mil
(christina.boyd-brown@med.navy.mil, tameka.davis@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENT The Naval Medical Logistics Command intends to negotiate on a sole source basis IAW FAR 13 with Covidien Sales, LLC, 15 Hampshire St., Mansfield, MA 02048-1113, as the only responsible source that can provide a radiofrequency ablation generator system radiology data management information system as required by Naval Medical Center San Diego, CA. The requirement is for a radiofrequency therapy system, tissue ablation. The system shall be capable of treating Barrett's esophagus. This shall be accomplished by means of radiofrequency tissue ablation. This system shall include a radiofrequency ablation generator. The system shall also include a cart to allow it to be transportable. The radiofrequency generator shall have the ability to utilize both circumferential and focal catheters. The system shall include balloon catheters of diameters between 18 mm and 31 mm for the radiofrequency ablation treatment to be provided. The system shall also include focal catheters capable of treating area sizes of both 150 square millimeters, 260 square millimeters, and 520 square millimeters as well as endoscopic catheters. The radiofrequency generator shall also include a footswitch to facilitate hands-free operation of the instrument. The cart and catheters shall be compatible with the radiofrequency ablation generator. Training in-service shall be provided upon delivery. The electricity requirement is 110-120VAC, 60Hz. Vendor shall be an Original Equipment Manufacturer (OEM) maintenance contractor, 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. Any required maintenance shall be provided by original equipment manufacturer (OEM)-certified technicians and shall use only OEM-approved replacement parts and proprietary software. Regulatory Requirements: The system and all its 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 system shall be installed in compliance with OSHA requirements. Upon delivery, the vendor 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. This acquisition is being conducted under simplified acquisition procedures IAW FAR 13. There are no 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. Submit capability statements via email (using PDF, MS Word, Excel attachments) to Christina Boyd-Brown at christina.boyd-brown@med.navy.mil. Statements are due not later than 4:00 P.M. ET on 06 June 2014. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264514RCES055/listing.html)
- Place of Performance
- Address: 693 Neiman Street, Frederick, Maryland, 21703, United States
- Zip Code: 21703
- Zip Code: 21703
- Record
- SN03372667-W 20140523/140521234724-5cdab1de78391883a855386236af10c4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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