0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

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

510(k) Number

K191378 ↗

FDA Product Code

NGT

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Medline Industries, Inc. →

• What is the primary purpose of this pre-filled syringe, and how does it differ from standard saline flush solutions?

  This pre-filled COP syringe contains 0.9% Sodium Chloride Injection, USP, designed specifically as a vascular access flush to maintain intravenous catheter patency. Unlike standard saline flushes, it is pre-filled and ready for immediate single-use, eliminating the need for additional preparation or dilution. It is isotonic (308 mOsmol/L) and free of antimicrobial additives, ensuring compatibility with intravenous systems without introducing extra substances.

• Is this device intended for reuse, or is it strictly single-use? How should it be handled to maintain sterility?

  This device is strictly for single-use only, as explicitly stated in the product description. To maintain sterility, it should be handled using standard sterile intravenous solution protocols—keeping the package intact until use, avoiding contamination, and adhering to aseptic techniques during administration. The pre-filled design ensures no additional preparation is required, reducing the risk of exposure.

• What sizes or models of this pre-filled syringe are available, and how do they differ?

  The provided data lists multiple registration numbers (e.g., 3034669683, 1000122362, etc.), which correspond to different product codes (NGT) under the same classification. While exact volumes or model distinctions (e.g., syringe barrel length or plunger type) aren’t specified, these variations likely represent different packaging configurations or batch identifiers for the same 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe. For precise sizing, refer to the manufacturer’s labeling or technical documentation.

• How should this device be stored, and are there any special considerations for its shelf life or compatibility?

  Storage follows standard protocols for sterile intravenous solutions, meaning it should be kept in a cool, dry place away from direct sunlight until use. The device is not refrigerated unless specified otherwise on the packaging. Compatibility is ensured with intravenous systems and devices as it is isotonic (308 mOsmol/L) and free of antimicrobial additives, reducing the risk of adverse reactions. Always check the expiration date on the packaging before use.

• What regulatory pathway was followed for this device’s clearance, and how does that affect its use in hospitals?

  This device received FDA 510(k) clearance (K191378) under the Traditional pathway, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device (regulation 880.5200) and is intended for general hospital use, as indicated by the HO (Hospital) advisory committee. This clearance ensures it meets FDA standards for safety and effectiveness, allowing hospitals to use it confidently for vascular access flushing without additional regulatory hurdles.