SOURCES SOUGHT
65 -- ENROUTE Transcarotid Neuroprotection System (Delivery for VA Lebanon) This is Brand Name Only. This is not a request for quotes.
- Notice Date
- 1/17/2023 8:14:04 AM
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24423Q0333
- Response Due
- 1/24/2023 1:30:00 PM
- Archive Date
- 04/24/2023
- Point of Contact
- Allan Tabliago, Contract Specialist, Phone: 215-823-5800
- E-Mail Address
-
allan.tabliago@va.gov
(allan.tabliago@va.gov)
- Awardee
- null
- Description
- THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this sources sought notice. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. No solicitation exists. Therefore, do not request a copy of a solicitation. See instructions on page 5. ENROUTE Transcarotid Neuroprotection System (Brand Name Only) INTRODUCTION/BACKGROUND: The ENROUTE Transcarotid Neuroprotection System provides direct carotid access with robust flow reversal prior to crossing the lesion for embolic protection during angioplasty and stenting. The device removes micro and macro emboli throughout the intervention for CEA-like neuroprotection in a less invasive approach. The ENROUTE Transcarotid Neuroprotection System prevents embolic debris from flowing to the brain during carotid revascularization by reversing blood flow away from the brain. The flow reversal method does not rely on a distally placed filter to capture emboli before they reach the brain. Instead, a filter in the flow controller collects both small and large debris and filtered blood is returned via a sheath in the femoral vein. OBJECTIVE: The Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center hereby referred to as the Lebanon VAMC, is requesting the Brand Name only acquisition of the following: Three (3), ENROUTE Transcarotid Neuroprotection System MAJOR REQUIREMENTS: The Contractor/Vendor must complete the following tasks to meet the needs of this acquisition: See Paragraph 3.3 Table 1 for requirement Salient Characteristics for Brand Name ENROUTE Transcarotid Neuroprotection System Transcarotid Arterial Sheath with Arterial Dilator Uber-flex sheath tip with 15° anterior bias Depth markers to aid in sheath insertion Removable sheath stopper Flow Controller with Filter: 200 filter designed to capture micro and macro emboli during TCAR device delivery and deployment Venous Return Sheath with Venous Dilator: 4mm radiopaque tip for visibility .035 Extra Support, J-Tip Guidewire Short length designed for TCAR: 90cm Nitinol core, teflon coated Table 1 Line No. Part No. Description Qty 0001 SR-200-NPS ENROUTE Transcarotid Neuroprotection System 3 0002 SR-0620-CS ENROUTE Transcarotid Stent System 6x20 1 0003 SR-0630-CS ENROUTE Transcarotid Stent System 6x30 1 0004 SR-0640-CS ENROUTE Transcarotid Stent System 6x40 1 0005 SR-0730-CS ENROUTE Transcarotid Stent System 7x30 2 0006 SR-0740-CS ENROUTE Transcarotid Stent System 7x40 2 0007 SR-0830-CS ENROUTE Transcarotid Stent System 8x30 2 0008 SR-0840-CS ENROUTE Transcarotid Stent System 8x40 2 0009 SR-0930-CS ENROUTE Transcarotid Stent System 9x30 2 0010 SR-0940-CS ENROUTE Transcarotid Stent System 9x40 2 0011 SR-1030-CS ENROUTE Transcarotid Stent System 10x30 2 0012 SR-1040-CS ENROUTE Transcarotid Stent System 10x40 2 0013 SR-4025-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 4x25 1 0014 SR-4035-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 4x35 1 0015 SR-4525-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 4.5x25 1 0016 SR-4535-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 4.5x35 1 0017 SR-5025-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 6x35 1 0018 SR-5035-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 5x35 1 0019 SR-5525-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 5.5x25 1 0020 SR-5535-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 5.5x35 1 0021 SR-6025-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 6x25 1 0022 SR-6035-BC ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter 6x35 1 0023 SR-4F21G7D-MP Sterile Micro Introducer Kit, Galt 7cm 1 0024 SR-014-GW ENROUTE 0.014"" Guidewires 1 The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor s employees. POINT OF CONTACT (POC): The identified POC and technical representative for this acquisition is: Name: Beverly Miller Phone Number: 717-272-6621x4120 Email: beverly.miller1@va.gov ""No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."" REPORTS/DELIVERABLES: Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Lebanon (595). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. REQUEST FOR INFORMATION INSTRUCTIONS: The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339113 (size standard of 500 employees). Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees; Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. Please provide your UEI number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to allan.tabliago@va.gov no later than, 16:30 PM Eastern Standard Time (EST) on January 24, 2022. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Allan Tabliago. Questions or responses will include the Source Sought number in the subject line. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. Any interested business concern must submit a no longer that 10-page capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer. If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at allan.tabliago@va.gov. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/3575cf95b976430990c2def08f2587c8/view)
- Place of Performance
- Address: Department of Veterans Affairs Lebanon VAMC 1700 S Lincoln Ave., Lebanon 17042, USA
- Zip Code: 17042
- Country: USA
- Zip Code: 17042
- Record
- SN06566057-F 20230119/230117230109 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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