Pro-Vent Pulsator Arterial Blood Sampling Syringes

• • Terminated Z-3196-2018 FDA Class III ·initiated 13 Jul 2018

  The product was mislabeled with the incorrect label.

510(k) Number

K981035 ↗

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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• Cpap System, Model 102001

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See all devices from Sims Portex, Inc. →

• What is the Pro-Vent Pulsator Arterial Blood Sampling Syringe used for?

  The Pro-Vent Pulsator Arterial Blood Sampling Syringe is specifically designed for collecting arterial blood specimens. Its dry lithium heparin anticoagulant ensures proper anticoagulation while minimizing interference with test results, delivering more accurate and consistent laboratory measurements. The venting filter and air bubble removal feature streamline the collection process, reducing patient discomfort during sampling.

• Are these syringes sterile and single-use?

  Yes, the Pro-Vent Pulsator Arterial Blood Sampling Syringes are supplied sterile and intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintains the integrity of the specimen for reliable diagnostic testing.

• What sizes are available for the Pro-Vent Pulsator Arterial Blood Sampling Syringes?

  The Pro-Vent Pulsator Arterial Blood Sampling Syringes are available in a 3 mL volume. This size is optimized for arterial blood collection, balancing sufficient specimen volume with ease of handling and patient comfort during the procedure.

• How does the venting filter and air bubble removal device improve the sampling process?

  The venting filter allows air to escape during filling, preventing air bubbles from entering the specimen, which can interfere with test accuracy. The air bubble removal device further ensures a clear, uninterrupted sample by eliminating trapped air before sealing the syringe. This design reduces the risk of inaccurate lab results and minimizes patient discomfort by enabling quicker, smoother blood collection.

• How should these syringes be stored?

  While the exact storage instructions are not detailed in the provided data, sterile single-use syringes like these are typically stored in a clean, dry environment protected from direct sunlight and extreme temperatures. It is important to follow the manufacturer’s specific guidelines to maintain sterility and device integrity until use. Always check the packaging for any additional storage recommendations.