SOLICITATION NOTICE
65 -- Continuous Renal Replacement Therapy Hemodialysis Unit
- Notice Date
- 3/27/2012
- Notice Type
- Presolicitation
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
- ZIP Code
- 00000
- Solicitation Number
- N626452RCES079
- Response Due
- 4/11/2012
- Archive Date
- 6/30/2012
- 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 Gambro Renal Products, Inc., 14143 Denver W Pkwy Suite 400, Lakewood, CO 80401, as the only responsible source that can provide a continuous renal replacement therapy hemodialysis unit that is capable of meeting the minimum requirements of the government. The requirement is for one continuous renal replacement therapy hemodialysis unit. Consumable components of the unit shall include a filter, an extracorporeal circuit, and therapy fluids. The unit shall be capable of operating in all of the following modes: slow continuous ultrafiltration (SCUF), continuous venovenous hemodialysis (CVVHD), continuous venovenous hemofiltration (CVVHF), and continuous venovenous hemodiafiltration (CVVHDF). The unit shall have an integrated heparin pump. The unit shall be capable of an operating range of at least 10-450 ml/min for blood flow rate. The unit shall be capable of an operating range of at least 5-6,000 ml/min for dialysate flow rate. The unit shall be capable of an operating range of at least 0-6,000 ml/min for effluent flow rate. The unit shall have pressure sensors located at the filter, on the access blood lines, and return blood lines, at a minimum. The unit shall have an air detector/sensor on the return line. The unit shall have a blood leak detector/sensor that continually monitors the effluent line for red blood cells. The unit shall have a return-line clamp on the return blood line. The unit shall employ means to prevent electrostatic interference. None of the system components shall contain PVC or DEHP. The unit shall not require a specialized water purification system and shall not require a facility hook-up for water or a drain. Electrical requirements are 120 VAC, 60 Hz, 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. 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. 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 FAR 13. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 423450 with a small business size standard of 100. 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 11 April 2012. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N626452RCES079/listing.html)
- Record
- SN02706812-W 20120329/120327235501-5c957c41a7f3ba2d9cbde90a4e1b39ea (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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