Product Classification

• 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 Code: PNR
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.5980
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 5-123 ISO 80369-3 First Edition 2016-07-01
  Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
• 5-139 ISO 18250-3 First edition 2018-06
  Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application

Third Party Review

Not Third Party Eligible