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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 12, 2018 FBO #6167
SOURCES SOUGHT

65 -- Extracorporeal Life Support (ECLS) devices - Attachment 1

Notice Date
10/10/2018
 
Notice Type
Sources Sought
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
 
ZIP Code
21702-5014
 
Solicitation Number
W81XWH19R0004RFI
 
Archive Date
11/13/2018
 
Point of Contact
Maribel C. Fratina, Phone: 3016197731
 
E-Mail Address
maribel.c.fratina.civ@mail.mil
(maribel.c.fratina.civ@mail.mil)
 
Small Business Set-Aside
N/A
 
Description
A07 Request For Information - Attachment 3 A07 RFI Attachment 2 A07 RFI Attachment 1 1.0 SUBJECT: This is a Request for Information (RFI) ONLY. The U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Materiel Development Activity (USAMMDA), Combat Trauma and Acute Rehabilitation (CTAR), Program Management Office (PMO), located at FT. Detrick, MD, for the purchase of six (6) Good Manufacturing Practice (GMP) (ISO 9001 and/or ISO 13485 compliant) Extracorporeal Life Support (ECLS) devices along with 12 sets of their associated consumables (i.e., catheters, oxygen, dialysate, 2 maintenance kits, and operation and maintenance training on the device etc.). 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes, it does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responses will be used for market research purposes only. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested vendor's expense. Not responding to this RFI does not preclude participation in any future RFP, if one is issued, all information received in response to this RFI that is marked Proprietary, will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. This proposed procurement will be under North American Industry Classification System Code (NAICS) 339112 Surgical and Medical Instrument Manufacturing. Business size standard is 1,000 employees. 3.0 DESCRIPTION: This Request for Information (RFI) ONLY is seeking entities interested in providing six (6) Good Manufacturing Practice (GMP) (ISO 9001 and/or ISO 13485 compliant) Extracorporeal Life Support (ECLS) devices along with 12 sets of their associated consumables (i.e., catheters, oxygen, dialysate, 2 maintenance kits, and operation and maintenance training on the device etc.). The ECLS devices must provide kidney support through continuous renal replacement therapy (CRRT) and provide lung support either through carbon dioxide (CO2) removal or full oxygenation and be approved for such an indication by a regulatory body. The Extracorporeal Life Support (ECLS) - Lung/Renal (L/R) Devices will be used by trained care providers at Role of Care (RoC) 3 initially, with a potential for use at RoC 2. The ECLS device will be used on patients suffering from multi-organ failure, specifically patients with lung and kidney injuries. The ECLS device will also provide similar function to dialysis machines for patients with acute kidney injuries. The ECLS device will also be used for purposes as a bridge to long term therapy, mostly applied in prolonged care scenarios where evacuation times are extended. Please see Attachment 1, Attachment 2, and Attachment 3 for full RFI details and specifications. 4.0 SUBMISSION INSTRUCTIONS: The Government is seeking sources, Capability Statements, and industry feedback for this requirement for six (6) Good Manufacturing Practice (GMP) (ISO 9001 and/or ISO 13485 compliant) Extracorporeal Life Support (ECLS) devices along with 12 sets of their associated consumables (i.e., catheters, oxygen, dialysate, 2 maintenance kits, and operation and maintenance training on the device etc.). Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to provide the described product, including any necessary lead time. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e., small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please list any feedback accordingly (marked as vendor feedback) following your capability statement. This notice is NOT a request for competitive quotes; no solicitation document is available and telephone requests will not be accepted. However, sources may submit descriptive literature, fully documenting their capability to supply the instruments which shall be considered by the Agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. 5.0 SUBMISSION CONTACT INFORMATION: All Capabilities Statements are to be submitted as an electronic response, in Microsoft Office format and/or Portable Document Format (PDF) to this Request For Information (RFI) Notice NLT Monday, 29 October 2018, 3:00 PM EST. All responses submitted shall be unclassified and MUST be e-mailed. Interested entities shall forward submissions to Ms. Maribel C. Fratina, maribel.c.fratina.civ@mail.mil. Mail and telephone inquiries will not be accepted or acknowledged and no feedback or evaluations will be provided to companies regarding their submissions.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH19R0004RFI/listing.html)
 
Place of Performance
Address: US Army Medical Materiel Development Activity (USAMMDA), 1430 Veterans Drive, Fort Detrick, MD 21702-5009, Frederick, Maryland, 21072, United States
Zip Code: 21072
 
Record
SN05119234-W 20181012/181010230732-7ddd0c466c0d72200b052d641b91b61c (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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