Marksman Arterial Blood Gas Syringe

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

510(k) Number

K931924 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Marksman Arterial Blood Gas Syringe used for?

  The Marksman Arterial Blood Gas Syringe is designed specifically for collecting and analyzing arterial blood samples in clinical chemistry applications. It provides accurate measurements of critical blood gas parameters, including pH, partial pressures of oxygen (PaO₂) and carbon dioxide (PaCO₂), and bicarbonate levels. This precision is essential for diagnosing and monitoring respiratory and metabolic conditions in patients, particularly in intensive care settings where rapid and reliable results are required.

• Is the Marksman Arterial Blood Gas Syringe single-use or reusable?

  The Marksman Arterial Blood Gas Syringe is intended for single-use only. It is supplied as a sterile disposable device to ensure patient safety and maintain the integrity of blood gas analysis. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and accuracy.

• How should the Marksman Arterial Blood Gas Syringe be stored?

  The syringe must be stored according to standard aseptic protocols to preserve its sterility and functionality. It should be kept in its original packaging until use, protected from contamination, moisture, and physical damage. Exposure to extreme temperatures or direct sunlight should be avoided, as these conditions could degrade the device’s performance or integrity.

• What regulatory clearance does the Marksman Arterial Blood Gas Syringe hold?

  The device has received FDA 510(k) clearance under the product code JKA, with clearance number K931924. This classification confirms it is substantially equivalent to predicate devices in the clinical chemistry category, meeting regulatory standards for blood collection systems used in arterial blood gas analysis.

• Are there different sizes or models of the Marksman Arterial Blood Gas Syringe?

  The provided device data does not specify multiple sizes or models for the Marksman Arterial Blood Gas Syringe. However, it is designed as a single-use, sterile disposable syringe for arterial blood collection. If variations exist, they would likely be documented in the manufacturer’s technical specifications or product literature, which should be consulted for detailed information.