IBC Quick Cell Component (1/2, 3/8, 1/4)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K955380 ↗

FDA Product Code

DRY

Device Class

Class II

Regulation

21 CFR Part 870.4330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4

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• Accuflo Monitoring System (1800)/ Accuflo Probe (8000)

  Class II

  FDA 510(k) K963703 Active Cleared 8 Apr 1998

See all devices from International Biophysics Corp. →

• What specific blood gas measurements does the IBC Quick Cell Component enable during cardiopulmonary bypass procedures?

  The IBC Quick Cell Component is designed to measure arterial and venous blood gases in real-time, including oxygen (O₂), carbon dioxide (CO₂), and pH levels. These measurements are critical for intraoperative monitoring during cardiac procedures to ensure proper oxygenation, ventilation, and acid-base balance of the patient’s blood while on bypass.

• Is the IBC Quick Cell Component reusable, or is it intended for single-use only?

  The IBC Quick Cell Component is explicitly supplied as a single-use, dry device. It is not intended for reuse or sterilization beyond the manufacturer-provided packaging, which ensures sterility for one-time use in a cardiopulmonary bypass system.

• Which blood-gas monitoring systems is this component compatible with, and how is it integrated?

  The IBC Quick Cell Component is designed for integration with compatible blood-gas monitoring systems, such as the CDI Model 400. It is intended to be used as part of a cardiopulmonary bypass setup, where it facilitates real-time monitoring by connecting to the system’s measurement infrastructure.

• What sizes are available for the IBC Quick Cell Component, and how might this affect its use?

  The IBC Quick Cell Component is available in three sizes: 1/2 inch, 3/8 inch, and 1/4 inch. These sizes likely correspond to tubing or connector dimensions within cardiopulmonary bypass circuits, allowing clinicians to select the appropriate size based on the specific setup and patient requirements.

• How is the sterility of the IBC Quick Cell Component maintained, and what storage instructions should be followed?

  The device is supplied in sterile packaging and requires no additional sterilization beyond what the manufacturer provides. It should be stored according to the packaging instructions to preserve sterility until use, typically in a clean, dry environment away from direct sunlight or extreme temperatures.