Sterile Medical Device Packaging and Labeling
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AI Contract Overview
The contract involves the subcontracting of sterile medical device packaging, sterilization validation, labeling, and kitting specifically for the Transcatheter Aortic Valve Replacement (TAVR) system, intended for medical use. It ensures that all processes comply with stringent FDA and Department of Veterans Affairs requirements, maintaining the highest standards of sterility and safety for this critical medical technology. The contract falls under NAICS code 326199, which corresponds to other plastics product manufacturing, reflecting the technical and specialized nature of the packaging and labeling work involved. Managed by the Network Contract Office 23 of the Department of Veterans Affairs, this agreement does not specify detailed set-aside provisions or the exact location for performance. The scope emphasizes adherence to regulatory standards and quality assurance protocols to support the deployment of the TAVR system in healthcare settings. The focus on validation and compliant labeling highlights the contract’s role in ensuring that the medical device is safe and ready for clinical use.
General Info
Place of Performance
MNSet-Aside
Documents
This scope was carved out of 36C26326Q0461.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
6515--PROS V23 618 UNU BILL & REPLACE 6182923579 (MI) TAVR (NEED ON OR BEFORE 3/17/2026) (VA-26-00053316)
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