The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Gambro Renal Products of 14143 Denver West Parkway, Lakewood, CO 80401. United States Naval Hospital Guam has a requirement for fluids and filters for use in continuous renal replacement therapy (CRRT). The fluids and filters shall be compatible with the installed base of Gambro Prismaflex units for CRRT. The fluids shall be sterile hemofiltration and hemodiafiltration solutions; these shall be bicarbonate-based. The fluids shall have formulations containing calcium and formulations that are calcium-free. The filters shall allow for diffusion of waste products out of the blood. The filters shall be capable of accommodating blood flow as low as 75 mL/minute and as high as 400 mL/min. The filters shall also have identifying barcodes which allow the Prismaflex systems to register the type of filter in use.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized distributor for the proposed supplies.

The systems 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.

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 [email protected]. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller, reference solicitation number N6264514RCES026. Email challenges are preferred. Closing date for challenges is no later than 2:00pm. ET on 22 April 2014. No phone calls will be accepted.

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