• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device enteral syringes with enteral specific connectors
Regulation Description Gastrointestinal tube and accessories.
Definition Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using aami/cn3(ps):2014 compliant connectors.
Physical State Plastic device with barrel, movable plunger, and connector.
Technical Method The device can be attached to a feeding tube or extension set to administer nutrition, medication, or hydration to a patient using AAMI/CN3(PS):2014 compliant connectors.
Target Area The gastrointestinal tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePNR
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 Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-