Water, Vascular Access Flush

Device Code: 2707

Product Code(s): NZX

Definition: Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.

Device Classification Information

• Device Type ID: 2707
• Device Name: Water, Vascular Access Flush
• Physical State: Liquid
• Technical Method: Physically Occupies Space Within The Vascular Catheter And Exerts Pressure On The Patient's Blood To Prevent Blood From Backfilling Into The Catheter And Clotting
• Target Area: Vascular Catheter
• Regulation Description: Intravascular Catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Infection Control Devices Branch (INCB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5200 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NZX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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
• 6-301 ISO 10555-1 Second Edition 2013-06-15
  Intravascular Catheters - Sterile And Single-use Intravascular Catheters - Part 1: General Requirements
• 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)]

Total Product Life Cycle

• Device Type ID: 2707
• Device: Water, Vascular Access Flush
• Product Code: NZX
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intravascular Catheter.
• CFR Regulation Number: 880.5200 [🔎]

TPLC Last Update: 2019-04-02 20:17:42