RFQ_W81XWH-19-Q-0015_ECLS_Amendment_A00001.pdf

QUESTION 1: You are looking for 7 brand name or equal ECLS Devices and 14 consumables, which are capable of replacing lung and kidney functions.

Here, with RFQ W81XWH-19-Q-0015, I understand you are looking for commercialized ECLS units enabling simultaneous lung/kidney support, with

NAICS code 339112. Therefore, I am wondering if the Pneuma-K ECLS System is what you are looking for. I feel that Pneuma-K ECLS System may not be a perfect match you need?

RESPONSE 1: The Government’s requirement is for commercially available ECLS units that are approved by a regulatory body (FDA approved or CE marked). If your device does not meet this qualification, you will not be seen as technically acceptable for this

RFQ.

QUESTION 2: Our company is most interested in partnering with you in reference to the above solicitation number. We need to know if any of the limitations listed in the attached response prevent us from qualifying for submitting the RFP.

RESPONSE 2: This is a Request for Quote (RFQ), not a Request for Proposal

(RFP). The RFQ process is meant for purchasing of technically acceptable equipment, whereas an RFP is used for developing a capability to meet a certain set of criteria. If your device does not currently meet the requirements listed in the RFQ, it will not be seen as technically acceptable for this RFQ.

PLEASE NOTE: Even if you did not meet all the Minimum Essential Characteristics (MECs) on the previously posted Request for Information (RFI) W81XWH-19-Q-0004, you can still provide your quote to current RFQ

W81XWH-19-Q-0015.

RFQ W81XWH-19-Q-0015 is extended to 3:00 PM EST on Friday, 22 February 2019.