6515--Impella Pump Set Brand Name or Equal

ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA $00.00 $00.00 CATHETER, IMPELLA 2.5 (AIC) MANUFACTURER PART NUMBER (MPN): 5042 LOCAL STOCK NUMBER: 5042 0002 2.00 EA $00.00 $00.00 IMPELLA CP PUMP SET MANUFACTURER PART NUMBER (MPN): 0048-0003 LOCAL STOCK NUMBER: 0048-0003 GRAND TOTAL $00.00 Department of Veterans Affairs Veterans Health Administration (VHA) Sources Sought Notice Obtain Catheter. This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of your company s offered services and capabilities. The Government will not pay any costs for responses submitted in response to this Source Sought Notice. This Sources Sought notice provides an opportunity for respondents to submit their capability and availability to provide the service requirement described below. Vendors are being invited to submit information relative to their potential to fulfill this requirement, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking to obtain brand name or equal Catheter and San Antonio, TX. Refer to the General Requirements section below for the requested product description. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy. General Requirements: Brand name or equal Catheter are needed for the San Antonio, TX in accordance with the following requirements: SALIENT CHARACTERISTICS: Impella 2.5 Pump Set (Part#: 005042) Impella CP Pump Set (Part#: 0048-0003) The Impella Catheter is an intravascular microaxial blood pump that supports a patient s circulatory system. The Impella 2.5 and Impella CP Catheters can be inserted percutaneously through the femoral or axillary artery and into the left ventricle. These Cathers deliver blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta. Physicians and Cath Lab Techs will continuously monitor the correct positioning and functioning of the Impella Catheter on the display screen of the Automated Impella Controller. Reusable System Components: Automated Impella Controller Provides the user interface, alarm indications, and portable battery Automated Impella Controller Cart For easy transport of the Automated Impella Controller Single-Use System Components: Impella Catheter Purge Cassette 0.018 inch, 260 cm placement guidewire Impella Axillary Insertion Kit Connector Cable Introducer Kit for the Impella 2.5 and CP Peel away introducer Dilator 18 gauge Seldinger needle 12cc syringe 0.0.35 inch stiff access guidewire Additional Information: Impella 2.5 Speed Range: 0 51,000 rpm Power Consumption: 19.8 W Voltage: Max. 20V DC Flow Maximum: 2.5 L/min Recommended Purge Fluid: 5% dextrose solution w/ heparin concentration of 50 IU per mL. Dextrose Concentration: 5% - 40% Purge Pressure: 300 1100 mmHg Infusion Rate: 2 30 mL/hr Length of Invasive Portion (w/o catheter): 130+/- 3mm Diameter: Max 4.2mm Latex: Not made w/ natural rubber latex Max. Duration of Use: 4 Days Impella CP Speed Range: 0 46,000 rpm Power Consumption: 24 W Voltage: Max. 20 V DC Flow Maximum: 3.3 L/min Recommended Purge Fluid: 5% dextrose solution w/ heparin concentration of 50 IU per mL. Dextrose Concentration: 5% - 40% Purge Pressure: 300 1100 mmHg Infusion Rate: 2 30 mL/hr Length of Invasive Portion (w/o catheter): 150+/- 3mm Diameter: Max 4.9mm Latex: Not made w/ natural rubber latex Max. Duration of Use: 4 Days 2.5 & CP Impella Pump set is a catheter pump system needed for patients that need emergency support for their heart muscle during interventional procedures in the Cath Lab. The catheter must have a dimeter of at least 9Fr with a flow rate up to 2.5 I/min thru a 12Fr pump motor. 52.211-6 Brand Name or Equal. As prescribed in 11.107(a), insert the following provision: Brand Name or Equal (Aug 1999) - - - (a) If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs. The salient physical, functional, or performance characteristics that equal products must meet are specified in the solicitation. - - - (b) To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must- - - - - - (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; - - - - - (2) Clearly identify the item by- - - - - - - - - (i) Brand name, if any; and - - - - - - - - (ii) Make or model number; - - - - - (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and - - - - - (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. - - - (c) The Contracting Officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. - - - (d) Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation. (End of clause) VAAR 852.212-72 Gray Market Items: a) Gray market items are Original Equipment Manufacturers' (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA Medical Centers. No remanufactures or gray market items will be acceptable. (b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM, such that the OEM's 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. (End of clause) FAR 52.212-2 Evaluation-Commercial Items: A copy of the authorized distributor letter from the contractor to verify that you are an authorized distributor of the products/services SHALL BE SUBMITTED WITH THE QUOTE AND IS MANDATORY!