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65--Implantable Electrodes from Ardiem Medical

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36C25019Q1070Federal

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The Cleveland Department of Veteran Affairs Medical Center plans to procure implantable multi-contact nerve cuff electrodes specifically designed to activate paralyzed arm muscles. These electrodes must fit around nerves and provide safe electrical stimulation through stimulation contacts, with adapter leads capable of passing through the skin for external connections. The devices must be FDA-approved for human use. This procurement will be conducted as a sole source acquisition under FAR 13.106(1)(b), meaning only one supplier is considered reasonably available, which in this case is Ardiem Medical, Inc., located in Indiana, PA. The small business size standard associated with this contract falls under NAICS code 335999, with a size limit of 500 employees. Interested parties, other than Ardiem Medical, may submit information by July 12, 2019, to demonstrate their capability to fulfill the requirement; however, submission does not guarantee competition. All responses will be evaluated to decide if the procurement should remain sole source or open for competition, with the final decision resting solely with the government. No formal solicitation has been issued yet, and all inquiries must be directed via email to the designated point of contact, referencing the specific RFQ number. The intention is to negotiate and solicit exclusively with Ardiem Medical unless compelling interest and capability from others are presented.

General Info

Cleveland VA seeks sole-source FDA-approved nerve cuff electrodes from Ardiem Medical, competition possible.

Agency

N/A

NAICS

335999 - All Other Miscellaneous Electrical Equipment and Component Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
ContactsNo contacts available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
ContactsNo contact information available

Full Description

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36C25019Q1070 SPECIAL NOTICE NOTICE OF INTENT TO SOLE SOURCE Implantable Electrodes The Cleveland Department of Veteran Affairs Medical Center, 10701 East Blvd Cleveland, OH 44106 intends to solicit and negotiate with only one source under the authority of FAR 13.106(1)(b)-Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The NAICS code is 335999 with a small business size standard of 500. The VA intends to solicit and negotiate with Ardiem Medical, Inc 1380 Route 286 East Indiana, PA 15701. The research department is requesting multi-contact nerve cuff electrodes to activate paralyzed muscles in the arm. The nerve cuff electrodes must be able to fit around a nerve and have stimulation contacts that can safely provide electrical stimulation. The adapter leads must connect to the nerve cuff electrode and be able to pass through the skin for external connections. Devices must be approved by the FDA for human use. Other persons may identify their interest and capability to respond to this requirement by Friday July 12, 2019 at 2PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. - All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Tiera Sims at contact@example.gov. Enter RFQ 36C25019Q1070| Implantable Electrodes in the email subject line.

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