Heparin, Vascular Access Flush

Device Code: 2706

Product Code(s): NZW

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: 2706
• Device Name: Heparin, Vascular Access Flush
• Physical State: Liquid Solution
• Technical Method: Physically Occupies Spacewithin 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: NZW
• 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)]
• 6-419 USP 41-NF36:2018
  Heparin Lock Flush Solution

Total Product Life Cycle

• Device Type ID: 2706
• Device: Heparin, Vascular Access Flush
• Product Code: NZW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intravascular Catheter.
• CFR Regulation Number: 880.5200 [🔎]

Premarket Reviews
Manufacturer	Decision
BD
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
EXCELSIOR MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXCELSIOR MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Patient-Device Incompatibility	1
Appropriate Term/Code Not Available	1
Total Device Problems	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Excelsior Medical Corp	II	Jun-14-2016
2	Fresenius Kabi USA, LLC	II	Jan-29-2015
3	Medefil Incorporated	III	Mar-06-2014

TPLC Last Update: 2019-04-02 20:17:41