P09. SOW- Salient Characteristics.docx

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6515--Dual lumen Cannula
Solicitation number
36C246-24-AP-1675
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This document is a Sources Sought notice issued by the Department of Veterans Affairs (VA) seeking information on potential sources to provide up to 10 ProtekDuo dual lumen cannulas in sizes 29Fr and 31Fr. The cannulas are required to have FDA approval, be single-use disposables, provide up to 6 hours of temporary cardiopulmonary bypass functionality, and the ability to be used with or without an oxygenator to deliver 5 L/min of flow and provide full right ventricular and oxygenation support. Respondents are requested to provide information on their business size, manufacturing capabilities, pricing, and ability to meet the salient characteristics of the required products. Responses are due by April 10, 2024. This Sources Sought notice is for information gathering purposes only and does not constitute a solicitation. Any resulting solicitation will require a separate response.

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Salient Characteristics Transaction #: 652-24-2-087-1390

(A) Functions to be performed;

· The ProtekDuo is a dual lumen cannula that provides temporary mechanical support for right heart failure. This device can be inserted “percutaneously” (injected through skin) into the right internal jugular vein vs. centrally and having to open the patient’s chest. By internal jugular vein insertion, the device allows the patient to ambulate. The device shall not be inserted into the femoral vein in the groin. Device shall deliver up to 5 L/min. Device shall provide centrifugal flow. Also, device shall have the ability to be converted into VV-ECMO, which means ability to add oxygenator to the circuit and oxygenate the patients’ blood, if necessary. The devices shall be 29FR and 31FR.

(B) Performance required;

· Dual Lumen Cannula

· RVAD/VV-ECMO task capability

· FDA Approved, 510(k) Clearance no. K232480.

· Single-use disposables.

· Up to 6-hour temporary cardiopulmonary bypass functionality

· Ability to be used with or without Oxygenator.

· Delivery 5 L/m flow rate.

· Optional ability to use with oxygenator.

· Allows full right ventricular and oxygenation support.

(C) Essential physical characteristics; Dimensions (if applicable)

· 29Fr cannula and 31Fr cannula

· 29Fr is 46cm long31Fr is 51cm long

File details come from the government source that posted it. Updated .