Medos Hilite Infant Oxygenator, Model 1000, 800 Lt

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

510(k) Number

K090449 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Gish Biomedical, Inc. →

• What is the Medos Hilite Infant Oxygenator 1000/800 LT used for?

  This device is designed for extracorporeal oxygenation and carbon dioxide removal during cardiopulmonary bypass procedures in neonatal and infant patients. It provides controlled gas exchange in low-flow applications, ensuring precise oxygenation for pediatric patients requiring temporary circulatory support.

• How are the Medos Hilite Infant Oxygenator models 1000 and 800 LT different?

  The Model 1000 is optimized for blood flow rates of 0.2 to 1.0 liters per minute, while the Model 800 LT supports lower flows of 0.2 to 0.8 liters per minute. Both are intended for neonatal and infant use but differ in their maximum blood flow capacity to match specific clinical needs.

• Is the Medos Hilite Infant Oxygenator single-use or reusable?

  The device is supplied as a single-use, sterile product. This ensures patient safety by eliminating the risk of cross-contamination between uses, adhering to best practices for sterile medical devices in controlled clinical environments.

• What storage conditions are required to maintain sterility and performance?

  The device must be stored under manufacturer-recommended conditions to preserve sterility and functionality. Proper storage prevents degradation and ensures the oxygenator remains effective for its intended use in operating rooms or intensive care units.

• Can the Medos Hilite Infant Oxygenator be used in MRI environments?

  No, the device is explicitly not MRI-compatible. It should only be used in non-MRI settings to avoid interference or safety risks associated with magnetic fields.