Heparin Lock / Flush Syringes

• • Ongoing Z-1596-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

510(k) Number

K133446 ↗

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

• Syrex Pre-Filled Syringe

  Class II

  FDA 510(k) K023740 Active Cleared 13 May 2003

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

  Class II

  FDA 510(k) K962938 Active Cleared 25 Oct 1996

See all devices from Excelsior Medical LLC →