Product Classification

• Device: administration set docking station
• Regulation Description: Intravascular administration set.
• Definition: Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
• Physical State: Housing is made of polyethylene, piston is made of silicone
• Technical Method: Temporary barrier against airborne contaminants
• Target Area: indirect contact, intravascular administration of fluids
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: ODI
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5440
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-447 ISO 8536-4 Sixth edition 2019-09
  Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Third Party Review

Not Third Party Eligible