Hemostatic Gauze, Kaolin-Based
ID: MW-2405-26Type: Combined Synopsis/Solicitation
Overview

Buyer

DEPT OF DEFENSEDEFENSE LOGISTICS AGENCYDLA TROOP SUPPORTPHILADELPHIA, PA, 19111, USA

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

PSC

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES (6515)

Original Source

https://sam.gov/opp/0ca9248101d14d408fc0a1f0fbac00dd/view
Timeline
    Description

    The Department of Defense, through the Defense Logistics Agency Troop Support, is seeking vendors to qualify for a Qualified Suppliers Listing (QSL) for Hemostatic Gauze, Kaolin-Based products. This initiative aims to establish a list of approved suppliers for products essential for Military Treatment Facilities (MTFs) and various military branches, with an estimated annual sales volume exceeding $7.3 million. Vendors must meet specific requirements, including having a valid DAPA number, agreements with DoD Medical/Surgical Prime Vendors, and compliance with FDA and Trade Agreements Act regulations. Interested vendors must submit their qualifications by October 17, 2024, to the designated contacts, Dr. Jim Quinn and Mr. David Sheaffer, via email, to be considered for inclusion in the QSL and subsequent pricing quote opportunities.

    Point(s) of Contact
    Dr. Jim Quinn Lead MMESO South Clinical Analyst Contractor
    james.e.quinn28.ctr@health.mil
    David Sheaffer MMESO South Team Leader Contractor
    david.v.sheaffer.ctr@health.mil
    Files
    Title
    Posted
    QSL Announcement MW-2405-26 Hemost Gauze Kaolin-Based.docx
    The Defense Health Agency (DHA) is seeking responses for a Sources Sought notification to create a Qualified Suppliers Listing (QSL) for Hemostatic Gauze, Kaolin-Based products. This initiative involves Military Treatment Facilities (MTFs) and various military branches with an estimated annual sales volume of over $7.3 million. Vendors are required to submit their qualifications by October 17, 2024, to be evaluated for inclusion in the QSL, which is essential for the subsequent Standardization Action. Requirements for participation include having a valid DAPA number, agreements with DoD Medical/Surgical Prime Vendors (Cardinal Health and Owens & Minor), and compliance with Trade Agreements Act regulations. Vendors must also provide detailed product information, including specifications and supporting documentation, to demonstrate FDA compliance and sterility of the products. Key specifications involve ensuring products are not made with natural rubber latex, are x-ray detectable, and possess appropriate packaging for moisture prevention. Participating vendors will be invited to submit pricing quotes after qualifying, understanding that being included on the QSL does not guarantee a contract or specific sales volume. The document outlines deadlines, submission procedures, and requirements for both technical and validation processes associated with this procurement initiative.
    QSL Package Worksheet MW-2405-26 HEMOST GAUZE KAOLIN-BASED.xlsx
    The document outlines the requirements for vendors aiming to qualify for the Department of Defense (DoD) Medical/Surgical Prime Vendor program, specifically concerning the supply of Hemostatic Gauze, Kaolin-Based products. Vendors must possess a DAPA (Drug Accountability and Procurement Agreement) or be in the process of applying for one and have an agreement with a current DoD Medical/Surgical Prime Vendor such as Cardinal Health or Owens & Minor. Specific product requirements include providing detailed descriptions, part numbers, and ensuring products are sterile, individually packaged, latex-free, and x-ray detectable. Vendors must also validate their accounts as active in the System for Award Management (SAM) and submit necessary documentation, such as packaging images and letters of attestation, confirming compliance with various regulations, including FDA standards. The structure of the document is systematic, with clear vendor instructions, product specifications, and requirements for documentation to ensure compliance with the DoD's stringent procurement guidelines. This ensures only qualified vendors participate in the program, emphasizing safety, regulatory compliance, and operational integrity within the healthcare procurement processes of the federal government.
    Lifecycle
    Title
    Type
    Hemostatic Gauze, Kaolin-Based
    Currently viewing
    Combined Synopsis/Solicitation
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