SOURCES SOUGHT
46 -- Field Intravenous Reconstitution (FIVR)
- Notice Date
- 2/25/2005
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, HSW - 311 Human Systems Wing, 311th HSW/PK 8150 Aeromedical Road, Brooks AFB, TX, 78235-5123
- ZIP Code
- 78235-5123
- Solicitation Number
- Reference-Number-FIVR2005
- Response Due
- 3/21/2005
- Archive Date
- 4/5/2005
- Description
- SUBJECT: Request for Information (RFI) for Field Intravenous Reconstitution (FIVR) The Air Force Human Systems Group is seeking information from sources that are capable of providing a portable sterile water generator capable of producing a variety of IV fluids from potable water available in the theater of operation. This device mixes and seals sterile IV fluids for immediate use or storage. The following capabilities are desired: (If device does not currently meet the following capabilities, respondents should supply supporting information on progress towards meeting these capabilities.) - Fluid will be to USP Standards for Sterile Water & IV Fluid mixtures - FDA guidance on Class II Special Controls Guidance Document Pharmacy Compounding Devices as applicable - Approved by the FDA as a medical device in accordance with federal law. - Will not exceed eighty (80) lbs - Total volume will not exceed three (3) cubic feet - Produce packaged IV fluids or sterile water at a rate of ten (10) liters per hour Additionally the following information is required: - A complete product description to include capabilities at a minimum. - Preliminary unit cost projections or preliminary developmental cost projections - Certifications the device has received or that are being sought (e.g., FDA approval) - Estimated delivery time after contract award. - Current points of contact for any government contracts you have for similar items. - Any information regarding the length of warranty and what is covered. - Limitations on seller?s liability. - A description of quality assurance provided in production. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the government. This is NOT a Request for Proposal, Invitation for Bid, or an announcement of a solicitation. Response to this RFI is strictly voluntary and will not affect any corporation's ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The purpose of this document is to identify potential sources. Any requests for a solicitation package will be disregarded. For submissions to be considered, developers/sponsors must electronically supply (.doc or .pdf format) the preceding information in the order and format in which it is presented to Ms. Jean Martinez, jean.martinez@brooks.af.mil or Capt. Gregory Santiago, gregory.santiago@brooks.af.mil no later than 1700, March 21, 2005. Telephonic responses will not be accepted. Electronic Media can be mailed to HSG/YASK, 7980 Lindbergh Landing, Brooks City-Base TX 78235-5119, ATTN: Ms Jean Martinez or Capt Gregory Santiago. Questions may be submitted to Capt. Gregory Santiago, gregory.santiago@brooks.af.mil. The Government does not intend to award a contract on the basis of this RFI or otherwise pay for the information solicited. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of preparing submissions in responses to this RFI and the Government's use of such information. Submittals will not be returned to the sender. Respondents of this RFI may be requested to provide additional information/details based on their initial submittals. The Government recognizes that proprietary data may be part of this effort. If so, clearly mark such restricted or proprietary data and present it as an addendum to the non-restricted/non-proprietary information. The Government shall not be liable for or suffer any consequential damages for any improperly identified proprietary information. Proprietary information will be safeguarded in accordance with the applicable Government regulations. The Government reserves the right to select one, some, or none of the submissions for further investigation. Submissions shall not exceed ten (10) 8.5 X 11 inch, single-sided pages per product. Product Material Safety Data Sheets (MSDS), independent technical reports, and laboratory reports may be attached in an appendix and will not count against the length requirement. Vendors who submit packages for review do so with the understanding that U.S. Government personnel as well as their support contractors will review their material and data. Respondents will not be contacted regarding their submission or information gathered as a result of this notice nor the outcome of the Government's review of the solicited information.
- Place of Performance
- Address: 7980 Lindbergh Landing/Brooks City-Base/TX
- Zip Code: 78235
- Country: USA
- Zip Code: 78235
- Record
- SN00758668-W 20050227/050225212120 (fbodaily.com)
- Source
-
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