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65--LAPROSCOPIC INSULATION TESTER reserved po 523A30324

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VA24114Q0045Federal

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The VA Boston Healthcare System plans to negotiate a sole source contract with Spectrum for a laparoscopic insulation tester, citing FAR 6.302-1 that allows for procurement from only one responsible source when no other supplies or services meet the agency’s requirements. The device is a portable, hand-held insulation tester housed in a heavy-duty, shock-resistant case, operating on a single 9-volt battery and including all necessary accessories along with a storage case. It has FDA 510(k) approval, ensuring it meets regulatory standards. This tester is essential in the operating room for detecting invisible tears or cracks along the shaft and handle of laparoscopic instruments, which undergo frequent cleaning and can experience insulation wear that may pose safety risks during surgical procedures. The device supports the work of technicians, nurses, and doctors by verifying the integrity of surgical instruments, thus maintaining safety and efficacy. This notice is meant to inform interested parties and is not a solicitation for competitive proposals. Interested entities may express their interest and provide supporting documentation by October 30, 2013, to the designated contracting officer for consideration. The agency will use the information received solely to decide whether to proceed with a competitive procurement, with the final decision resting with the contracting officer. The contract relates to solicitation number VA24114Q0045 and is categorized under NAICS code 334510, which pertains to instruments and related products manufacturing.

General Info

VA Boston seeks sole source contract with Spectrum for FDA-approved laparoscopic insulation tester.

Agency

N/A

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Full Description

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The VA Boston Healthcare System (VABHS) intends to negotiate on a sole source basis pursuant to FAR 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements with Spectrum surgical instruments for Laparoscopic insulation tester. This requirement will include the following characteristics: Product Description T Portable, hand held Insulation Tester features a heavy-duty, shock-resistant case, includes all accessories and operates on a single 9-volt battery. A storage case is included. In addition, the device has received FDA 510(k) approval. The device assists in locating potentially dangerous tears and cracks along the shaft and handle of the laparoscopic instruments. Laparoscopes are constantly used within the OR to perform surgical procedures. The devices are cleaned after every use and this could result in tears or wear on the insulation tubing. Some tears can be seen though simple observation but the Insulation tester would serve as a verification instrument for any tears that are not easily seen or missed by the surgical team. The service is essential to the Technicians, nurses, doctors, and others to ensure effectiveness and efficacy. Salient Characteristics Portable, hand held Insulation Tester features a heavy-duty, shock-resistant case, includes all accessories and operates on a single 9-volt battery. A storage case is included. In addition, the device has received FDA 510(k) approval. This Notice of Intent is NOT a request for competitive proposals. Parties may identify their interest, accompanied by supporting literature, to the Contracting Officer no later than 10/30/2013. Responses should be sent to contact@example.gov. Information received will be for the purpose of determining whether or not to conduct a competitive procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.

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