Syrex Pre-Filled Syringe

• • Terminated Z-1989-2016 FDA Class II ·initiated 28 Apr 2016

  Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.

510(k) Number

K023740 ↗

FDA Product Code

NZW

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Microbore Extension Set

  Class II

  FDA 510(k) K942349 Active Cleared 8 Feb 1995

• 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe

  Class II

  FDA 510(k) K142620 Active Cleared 12 Dec 2014

• Swabcap

  Class II

  FDA 510(k) K083508 Active Cleared 28 Apr 2009

• Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/Ml

  Class II

  FDA 510(k) K061497 Active Cleared 23 Feb 2007

• Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)

  Class II

  FDA 510(k) K962938 Active Cleared 25 Oct 1996

• Sterile Field Saline Pre-filled Syringe(s)

  Class II

  FDA 510(k) K082837 Active Cleared 18 Dec 2008

See all devices from Excelsior Medical LLC →