SOLICITATION NOTICE
65 -- Breast Biopsy System
- Notice Date
- 8/7/2013
- Notice Type
- Presolicitation
- 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
- N62645-13-T-0021
- Archive Date
- 9/6/2013
- 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 13.106(b) with Bard Peripheral Vascular, Inc., Tempe AZ 85281-2438, as the only responsible source that can provide a vacuum-assisted breast biopsy system which is capable of adjusting vacuum pressure up to 95 kPa under image guidance using ultrasound, x-ray, and magnetic resonance imaging as required by Naval Hospital Camp Lejeune, NC. The requirement is for a vacuum-assisted breast biopsy gun. The system shall be capable of automatic extraction of core tissue samples from the breast. The system shall be capable of use under image guidance using the following imaging modalities: ultrasound, x-ray, and magnetic resonance imaging. The system shall be capable of consistently penetrating and obtaining tissue samples in dense breast tissue. The system shall be capable of obtaining tissue samples assisted by vacuum pressure of up to at least 95 kPa. Vacuum pressure shall be adjustable. Onsite training shall be provided on delivery. The power requirement is 110V, 60Hz, single phase. 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. 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. This acquisition is being conducted under simplified acquisition procedures. 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 3:00 P.M. ET on 22 August 2013. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645-13-T-0021/listing.html)
- Place of Performance
- Address: Naval Medical Logistics Command, 693 Neiman Street, Fort Detrick, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN03140695-W 20130809/130808000050-a1907be237acbb10012467c18d414d4f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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