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The Department of Veterans Affairs is seeking information from vendors capable of providing Codonics Printers for pharmacy use, specifically a medication syringe labeling system that meets various regulatory and medical device requirements. Key requirements include FDA clearance, compliance with ISO standards, and the ability to integrate with existing systems for drug identification and labeling.
Vendors are requested to provide information on their capability to deliver a medication syringe labeling system that includes barcode scanning and printing capabilities, compliant with regulatory standards.
The North American Industry System (NAICS) is 339112 - Surgical and Medical Instrument Manufacturing The Service Code (PSC) is 6515 - Medical and Surgical Instruments, Equipment, and Supplies Responses to this notice shall include company/individual name, size status for the above reference NAICS code, a service capability statement, SAM Entity Unique Identifier (EUI), address,
point of contact, and examples of similar facilities to which similar items have been provided. Contractors must provide information on whether they are certified SDVOSB, VOSB, Hub zone, 8(a), women-owned concern. If standard company brochures will be provided as a response to this Source Sought ensure that additional information tailored to this notice is included.
This is not a solicitation for quotes. If a solicitation is issued, it will be announced on the Contract Opportunities website https: respond to that solicitation announcement separately from the response to this announcement. Contractors must be registered in System for Award Management (SAM), see internet site: https://www.sam.gov for information about registration. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? If you are in GSA, please provide schedule and contract number. Responses to this notice must be submitted via email to [email protected]. No telephone inquiries will be accepted. DISCLAIMER This Sources Sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought. Veterans Affairs, NCO-9, is seeking information for vendors interested and capable of providing the service below: Salient Characteristics 1. General Medication syringe labeling system for anesthesia/OR use that scans the drug vial/ampoule barcode, audibly and visually confirms drug identity, and prints a color, TJC-compliant syringe label at the point of preparation. Integrated point-of-care station includes touch-screen computer, 2D barcode scanner, color inkjet label printer, audio feedback, and network capability. 2. Regulatory / Medical Device
Requirements FDA 510(k)-cleared Class II medical device for medication syringe labeling (Safe Label System). CE-marked medical device (MDR 2017/745/EU Class I) and manufactured under ISO 13485-compliant quality system. Must support TJC, ASTM, and ISO standards for medication syringe labels, including drug class specific color and pattern per ASTM D4774 and ISO 26825 (or equivalent). 3. Core Functional
Requirements System must use barcode scanning of FDA NDC or equivalent drug container barcode to identify the medication and populate the label from a pharmacy-managed formulary. Provides on-screen text and audio confirmation of drug name and key attributes before printing, to mitigate vial/ampoule swaps and mislabeling errors. Prints water-resistant, full-color syringe labels including, at minimum: drug name, concentration, diluent and dilution (if applicable), expiration date and time, preparation date and time, preparer initials, applicable warnings, and a machine-readable barcode (1D and/or 2D). Pharmacy-driven formulary management with site-specific drugs, concentrations, diluents, and warnings, distributed to the device via SmartDrive USB and/or network connection. Must be capable of an Administer mode (or equivalent) in which the syringe label barcode can be scanned prior to administration to confirm contents and support documentation. 4. Printer / Label
Requirements Integrated color inkjet printer using a single CMY cartridge for syringe label media. Supports printing of ISO- and ASTM-conforming color fields, drug class color coding, and required text fields per syringe labeling standards and TJC recommendations. Produces durable, water-resistant labels suitable for OR/anesthesia use. Automatic label cutting with integrated label cutter; front-loading ink access and rear label-media loading. 5. Barcode and Data
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