ELECTRODE, IONTOPHORETI

The contract solicits two boxes of latex-free iontophoresis patches with a dose strength of 80 mA/min and a medication fill volume of 1.3 mL, designed as a disposable, single-use electronic transdermal drug delivery system for quick pain relief. These patches are classified as a Class II medical device regulated by the FDA under regulation 890.5525, requiring registration, listing, labeling, GMP compliance, and a 510(k) premarket notification. The item has a non-extendable shelf life of 24 months and is designated as a Type I (Code M) item under DLA requirements. Packaging must comply with MIL-STD-2073-1E and DLA Packaging Requirements (RP001), while marking adheres to Medical Marking Standard No. 1, superseding MIL-STD-129, with hazardous materials labeled per OSHA’s Hazard Communication Standard. Delivery is required within 20 days after order receipt to Fort Bliss, Texas, under FOB Destination terms. Bidders must provide the source and part number for the supplied item and, if submitting alternatives, must include a complete data package for both the approved and alternate part. Offers are subject to Pass/Fail Gates: inclusion of additive manufacturing without authorization disqualifies the bid, and failure to submit a compliant Safety Data Sheet before award results in non-responsibility. The procurement will be evaluated under automated award processes with potential HUBZone preference, and contractors must comply with all applicable Federal Acquisition Regulation clauses including cybersecurity safeguards (DFARS 252.204-7012), prohibition of covered telecommunications equipment (DFARS 252.204-7018), and restrictions on mandatory arbitration agreements. Payment must be processed electronically through the Wide Area Workflow system with both an invoice and receiving report submitted, and compliance with Buy American and Berry Amendment requirements applies due to the procurement value exceeding the micro-purchase threshold. The contract also mandates adherence to NIST SP 800-171 for safeguarding covered defense information and includes clauses addressing whistleblower protections, disclosure of information, and trafficking in persons.