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U.S. Department of Health and Human Services

Product Classification

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Device gastrointestinal tubes with enteral specific connectors
Regulation Description Gastrointestinal tube and accessories.
Definition To facilitate enteral specific connections.
Physical State plastic connector
Technical Method The connector is attached to an enteral tube and is intended to facilitate the administration of hydration, medication, and feed to a patient.
Target Area the gastrointestinal tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePIF
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
Third Party Review Not Third Party Eligible
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