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FBO DAILY ISSUE OF FEBRUARY 03, 2012 FBO #3723
SOLICITATION NOTICE

65 -- ENT Power Console

Notice Date
2/1/2012
 
Notice Type
Presolicitation
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
 
ZIP Code
00000
 
Solicitation Number
N62645RCES049
 
Response Due
2/16/2012
 
Archive Date
3/2/2012
 
Point of Contact
Derek Bell 301-619-6914
 
Small Business Set-Aside
N/A
 
Description
The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.106-1(b)(1)) with Medtronic USA Inc., 6743 Southpoint Drive, Jacksonville, FL 32216-6218, as the only responsible source that can provide a power console system and surgical handpiece that are capable of meeting the minimum requirements of the government. The requirement is for one surgical power system and one surgical handpiece to be used in Ears, Nose, and Throat (ENT) procedures. The power system shall be used to power, control and monitor electrical handpieces for use during sinus procedures, ear procedures and other types of ENT related surgeries. The system shall have connections for at least two different handpieces to be connected at one time. The system shall be capable of providing controlled continuous flow irrigation to the surgical field. Irrigant shall be supplied to the system from portable supplies of sterile fluid with no need for hard water facilities hookups. The system shall include a footpedal. The footpedal shall allow selection from attached handpieces, speed adjustment of selected handpiece, and mode selection of selected handpiece. The system shall have a digital display, at least 6 inches in size (diagonally), to display and select options and settings for each connected device. Power requirements are 110 VAC and 60 Hz. The surgical handpiece shall be capable of at least 5000 rpm in oscillatory mode and at least 1200 rpm in forward mode and shall be compatible with the power system. The surgical handpiece shall also be capable of operation in reverse mode. The surgical handpiece shall be of sufficient length to reach distal bronchial lesions. The surgical handpiece shall be capable of 360 degree blade rotation without removal from surgical site. The system shall include one sterilization tray to accommodate the surgical handpiece. The surgical handpiece shall be sterilizable by steam or by liquid detergent automated processing. 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. 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 system shall be installed in compliance with OSHA requirements. This acquisition is being conducted under simplified acquisition procedures FAR 13. 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. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Derek Bell at derek.bell@med.navy.mil. Statements are due not later than 4:00 PM EST on 16 Feb 2012. No phone calls accepted.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645RCES049/listing.html)
 
Record
SN02665917-W 20120203/120201235145-cfcd15b2db924e9c30f75599dbb11061 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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