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U.S. Department of Health and Human Services

Product Classification

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Device enteral specific transition connectors
Regulation Description Gastrointestinal tube and accessories.
Definition Facilitates enteral specific connections between aami/cn3(ps):2014 compliant connectors and non iso 80369-1 compliant legacy enteral connectors.
Physical State plastic connector
Technical Method A plastic connector that allows for AAMI/CN3(PS):2014 compliant connectors to connect to non ISO 80369-1 compliant legacy enteral connectors.
Target Area GI
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePIO
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type 510(k)
Regulation Number 876.5980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible