Product Classification

• Device: adminstration 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
• Submission Type: 510(k)
• Regulation Number: 880.5440
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
• 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

Third Party Review

Not Third Party Eligible