SPECIAL NOTICE
65 -- RFI-Chest_Seals
- Notice Date
- 7/12/2018
- Notice Type
- Special Notice
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- RFI-Chest_Seals
- Point of Contact
- Ms Vivian Alexander, Phone: (571) 231-5842, Mr. Gregory Morrison, Phone: 571-231-5905
- E-Mail Address
-
vivian.r.alexander.ctr@mail.mil, gregory.p.morrison.ctr@mail.mil
(vivian.r.alexander.ctr@mail.mil, gregory.p.morrison.ctr@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION (RFI) Chest Seals 1.0 Introduction 1.1 General. The purpose of this request is to obtain information from industry to support the government's intent to establish a Qualified Supplier List (QSL) for the standardization of Chest Seals. This RFI is an invitation to submit to the Defense Health Agency (DHA) Medical Logistics (MEDLOG) Division Medical Materiel Enterprise Standardization Office (MMESO) the following: technical information and all related supporting documentation for Chest Seals. This request is a market research effort undertaken by the government which will be used for information gathering purposes. The information received may be used for Acquisition Planning purposes and may help define future requirements for the subject item(s). This is not a request for quote or proposal. 1.2 RFI Submission Package. Vendors must provide responses to this RFI via the RFI Vendor Response Worksheet. Complete answers and all supporting documentation must be provided with the vendor's response. Responses for each salient characteristic should be in the form of yes, no, or alternate proposal. Although explanatory comments may be provided for all responses, they are required for "no" responses. 2.0 Scope Examples of items for this product line could include but are not limited to: Chest Seals designed to treat penetrating chest wounds. Vented and non-vented types to possibly include HyFin, Bolin, Halo, and/or Asherman styles. 3.0 Characteristics/Specification Feedback Requested : Respondents are requested to provide information concerning their Chest Seals regarding the following questions: 3.1 Are your Chest Seals manufactured in a TAA compliant country? Please supply the country of origin. 3.2 Are your Chest Seals FDA approved? Please provide supporting documentation. 3.3 Material 3.3.1 Are your Chest Seals made with natural rubber latex? 3.3.2 Please list any additional material from which your Chest Seals products are made. 3.4 Packaging and Units of Measure 3.4.1 Please list all packaging options you have available for Chest Seals products (e.g. case, box, pack, etc.). 3.4.2 Please list unit of measure for each packaging option (e.g. 1/pack, 2/pack, etc.). 3.4.3 Please list dimensions of each packaging option. 3.4.4 Please list all of the information you have printed on the packaging label at the end-user level (e.g. IFU, lot number, shelf life, product name, part number, etc.). 3.4.5 Please list material used for packaging Chest Seals at the end-user level (e.g. foil pouch). 3.4.6 Please list any additional packaging solutions/characteristics you may have (e.g. perforated, rugged, etc.). 3.5 Sterility 3.5.1 Do you have Sterile Chest Seals products? 3.5.2 How many sterile chest seals come in an end-user package? 3.5.3 Do you offer non-sterile Chest Seals products? 3.6 Chest Seals Styles Which of the following Chest Seal styles do you offer? 3.6.1 HALO 3.6.2 Bolin 3.6.3 HyFin 3.6.4 Asherman 3.6.5 H*VENT - please list number of ports for each H*VENT Chest Seal product available 3.6.6 Please indicate if offered Chest Seals are available in both vented and non-vented versions 3.6.7 Please list any additional Chest Seals styles you offer. 3.7 Vents 3.7.1 Please provide information on vent designs/configurations and provide part numbers. 3.7.2 Do you offer Chest Seal combination packaging? (I.e. (1) vented Chest seal and (2) non-vented chest seals). 3.8 Adhesive/Transparency 3.8.1 Please list all types of adhesive used with your Chest Seals products. 3.8.2 Please indicate which Chest Seal products can be reapplied to the trauma site if needed. 3.8.3 Please list part numbers for Chest Seal products that are transparent, if available. 3.8.4 Please list part numbers for Chest Seal products that are not transparent, if available. 3.9 Configurations and Dimensions (not packaging dimensions) 3.9.1 Please list all Chest Seal configurations (i.e. round, square, etc.) you have available. 3.9.2 Please list the size for each of Chest Seal configuration available. 3.10 Shelf Life 3.10.1 What is the shelf life of your Chest Seals? Please provide supporting documentation. 3.10.2 Is the shelf life information listed on the end-user packaging? 3.10.3 How and where is chest seal's expiration date documented? 3.11 Instructions for Use 3.11.1 Are instructions for use included with each product? 3.11.2 Are instructions for use printed on all end-user packaging? 3.11.3 Please list all forms in which you have provided instructions for use. 4.0 Feedback Requested Please complete the attached RFI Vendor Response Worksheet with indicated information about your Chest Seals. 4.1 Have your Chest Seals been subject to any recall(s)? If so, what corrective actions and/or product modifications have been made in response to the recall(s)? 4.2 Do you have any emerging Chest Seals technology you would like to share? 4.3 Please provide any additional information including relative topics outside of the specific information requested which you consider relevant. Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. All information, comments, and suggestions may be incorporated into future acquisition documents, without identifying the source or obtaining prior approval from the source. 5.0 Liability The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI. 6.0 RFI Responses The vendors' responses shall include all detailed information requested in the RFI Vendor Response Worksheet and shall also include: (1) Company name and address; (2) Company POC (Name and Phone Number, Fax Number, and E-mail address); and (3) Commercial and Government Entity (CAGE) Code. Points of Contact (POCs): Vivian Alexander, MMESO North Team Leader, 571-231-5842, vivian.r.alexander.ctr@mail.mil and Greg Morrison, MMESO North Clinical Analyst, 571-231-5905, gregory.p.morrison.ctr@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/RFI-Chest_Seals/listing.html)
- Place of Performance
- Address: Defense Health Agency, Universal Consulting Services, INC., 9275 Doerr Rd., Fort Belvoir, Virginia, 22060, United States
- Zip Code: 22060
- Zip Code: 22060
- Record
- SN04989257-W 20180714/180712231124-d493d860852b5237f08b02b433d71922 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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