Product Classification

• Device: heparin flush in 0.45% sodium chloride
• Regulation Description: Intravascular catheter.
• Definition: The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling. It provides an alternative to clinicians to prevent sodium overload in neonatal patients.
• Physical State: Transparent container, volume markings on the syringe barrel, tip cap, plunger stopper and Heparin Lock Flush solution
• Technical Method: Attaach syringe to access device and flush.
• Target Area: Heparin lock device or central venous catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: PEF
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 880.5200
• 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

• 3-176 ISO 18193 First edition 2021-08
  Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
• 3-183 ISO 11658 First edition 2012-05-15
  Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
• 6-408 ISO 10555-1 Second edition 2013-06-15
  Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
• 6-499 ISO 10555-1 Third edition 2023-11
  Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements

Third Party Review

Not Third Party Eligible