INDUSTRY RELATED RESOURCES
UNIQUE DEVICE
IDENTIFICATION RULE
TrackCore is compatible with the UDI barcode and all major barcode standards. TrackCore auto-populates the implant information including manufacturer, product description, serial number, lot number, etc. All vendors are required to uniquely label class III implants with 1 of 3 major barcode standards; GS1, HIBCC, ISBT and ICCBBA.
TRACKCORE'S DEDICATION
TO REGULATORY COMPLIANCE
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TrackCore was designed to comply with all FDA (CFR 21 Sections 1270 & 1271), TJC, DNV, HFAP, and CIHQ standards. TrackCore is the only solution reviewed by the Joint Commission Resources and covers all elements of the Transplant Safety Chapter. TrackCore meets or exceeds all CMS deeming authority organizations such as Det Norske Veritas (DNV), HealthCare Facilities Accreditation Program (HFAP), Center for Improvement in Healthcare Quality (CIHQ), The Joint Commission (TJC) and the Accreditation Association for Ambulatory Healthcare (AAAHC). TrackCore is committed to these standards and ensuring that hospitals remain compliant.
