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The proposed acquisition is for one (1) Photodynamic Diagnosis (PDD) System for the Urology department at Naval Medical Center San Diego. The system shall be FDA approved for Blue-Light Cystoscopy examinations.
Items being purchased in this acquisition:
One (1) Photodynamic Diagnosis (PDD) System and components.
The system shall be capable of identifying non-muscle invasive bladder carcinoma (NMIBC) by means of blue-light cystoscopy as well as performing traditional white light cystoscopy. The system shall be capable of delivering illumination to the tissue of the bladder with blue light (wavelength 380 nm-480 nm). The system shall be capable of providing fluorescence contrast visualization under blue light illumination. The system shall include a cart, central processing unit, 26" monitor with screen protector, light source, printer, bipolar electrosurgical unit with cart, cables and three (3) sets of instruments. Instruments shall include 30º and 70º telescopes, resectoscope sheaths, cysto-urethroscope sheaths, optical biopsy forceps, and sterilization trays. The power requirement is 120VAC, 60Hz.
Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems 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 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 FAR 8-4 Federal Supply Schedules. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System 334510 with a Small Business Size Standard of 500 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, company's who believe they can provide the requirement described above may submit technical data, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this notification 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. Any information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
This contract is estimated at $189,129.92 with open market items valued at $30,397.84
The Open Market items being purchased in this acquisition are as following and are the only components being advertised under this notice:
SONY UPDR80MD Medical Grade Printer Catalog# WU1271-UG
26" LED Monitor 1920 x 1080 Catalog# 9826NB-US-UG
26" Screen Protector Catalog# 9426HD-SP2
Image 1 Keyboard Kit Catalog# 20200130U
Video Cart with Full Door and Drawer Catalog# 9606A-UG
AUTOCON II 400 unit and 400B power cord Catalog# 20535202U125-US
External Resection Module Catalog# 20535280
Two pedal footswitch for HF Generators Catalog# 20017830
Capability statements shall be submitted by email only as a MS word or Adobe PDF attachment to [email protected]. Statements are due no later than 1:00 PM Eastern time on 31 March 2016. NO PHONE CALLS ACCEPTED.