Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride Solution

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K943830 ↗

FDA Product Code

JOL

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pre-Filled Sysringe W/Sterile Water

  Class II

  FDA 510(k) K943829 Active Cleared 21 Nov 1994

• Dual Port Enteral Y-Adaptor

  Class II

  FDA 510(k) K923168 Active Cleared 17 Jun 1994

• External Leg Bag

  Class I

  FDA 510(k) K901219 Active Cleared 27 Jun 1990

• Bulb Irrigation Tray

  Class II

  FDA 510(k) K900736 Active Cleared 17 Apr 1990

• Suction Catheter, Sterile

  Class I

  FDA 510(k) K902814 Active Cleared 17 Aug 1990

• Shave Prep Tray

  Not classified

  FDA 510(k) K902813 Active Cleared 19 Nov 1990

See all devices from Orion Life Systems, Inc. →

• What clinical purposes is this pre-filled syringe designed for in a hospital setting?

  This pre-filled syringe contains sterile 0.9% sodium chloride solution and is intended for irrigation, flushing, or dilution tasks in clinical environments. Its design ensures immediate availability, eliminating the need for manual preparation, which makes it practical for routine procedures requiring a sterile saline solution.

• Is this device single-use, and if so, why is that important for clinical workflows?

  Yes, this pre-filled syringe is explicitly labeled as a single-use device. This designation is critical for clinical workflows because it ensures sterility is maintained only for one procedure, reducing the risk of contamination and cross-infection. Single-use devices also simplify inventory management and disposal protocols, aligning with best practices for infection control.

• How is this device classified under regulatory standards, and what does that mean for its use?

  This device is classified under the FDA 510(k) pathway as a 'Catheter And Tip, Suction' product (product code JOL), with a substantially equivalent determination. This classification means it is intended for general hospital use—specifically for irrigation, flushing, or dilution—and is deemed comparable to existing devices already on the market. Clinically, this ensures it meets established safety and performance standards for those purposes.

• Are there any specific storage instructions provided for this pre-filled syringe?

  The available data does not explicitly detail storage conditions (e.g., temperature, humidity, or light exposure). However, since it is a sterile, single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use. Always follow manufacturer guidelines if additional instructions are provided elsewhere.