Sechrist Air/Oxygen Mixer Model 3500 CP-G
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023745 FDA 510(k)
- FDA Product Code
- DTX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4300 FDA 510(k)
- Regulation Number
- 870.4300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sechrist Air/Oxygen Mixer Model 3500 CP-G is a Gas Control Unit designed for cardiopulmonary bypass applications. It precisely blends air and oxygen to deliver controlled gas mixtures, ensuring accurate oxygenation during surgical procedures. This device is classified as a Class II medical device under FDA regulations, adhering to stringent performance standards for cardiovascular applications. Its functionality aligns with regulatory definitions for gas mixing systems used in critical care environments.
This device is intended for use in operating rooms and cardiac catheterization labs, where precise gas control is essential. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to maintain performance. The Model 3500 CP-G is authorized under an FDA 510(k) clearance (K023745) and falls under regulation 870.4300 for cardiopulmonary bypass systems. Storage and handling must comply with manufacturer guidelines to preserve functionality and sterility where applicable.
Frequently asked questions
What is the Sechrist Air/Oxygen Mixer Model 3500 CP-G used for?
The Sechrist Air/Oxygen Mixer Model 3500 CP-G is designed specifically for cardiopulmonary bypass applications. It blends air and oxygen with precision to maintain controlled gas mixtures during surgical procedures, particularly in operating rooms and cardiac catheterization labs where accurate oxygenation is critical. This ensures optimal patient outcomes by delivering the correct oxygen levels required for extracorporeal circulation.
Is the Sechrist Air/Oxygen Mixer Model 3500 CP-G reusable or single-use?
The Sechrist Air/Oxygen Mixer Model 3500 CP-G is supplied as a reusable medical instrument. Like other reusable devices in critical care, it requires regular maintenance, calibration, and cleaning to ensure consistent performance and reliability. Proper upkeep is essential to prevent contamination and maintain the device’s precision in gas mixing.
How should the Sechrist Air/Oxygen Mixer 3500 CP-G be stored?
Storage and handling of the Sechrist Air/Oxygen Mixer Model 3500 CP-G must follow the manufacturer’s guidelines to preserve its functionality. Since it is a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. If applicable, any components requiring sterility should be handled according to sterile processing protocols before use.
What regulatory approval does the Sechrist Air/Oxygen Mixer Model 3500 CP-G hold?
The Sechrist Air/Oxygen Mixer Model 3500 CP-G is authorized under an FDA 510(k) clearance with the reference number K023745. This clearance confirms that the device meets FDA performance standards for gas control units used in cardiopulmonary bypass systems, classified under regulation 870.4300. The device is also reviewed by the Cardiovascular (CV) Advisory Committee.
Does the device require any special maintenance beyond standard cleaning?
Yes, the Sechrist Air/Oxygen Mixer Model 3500 CP-G requires proper maintenance and calibration to ensure its accuracy in blending air and oxygen. Regular inspections should be conducted to verify that all components—such as sensors, valves, and control mechanisms—are functioning correctly. Calibration should align with the manufacturer’s recommendations to maintain the device’s precision, especially in high-stakes environments like cardiopulmonary bypass procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mixers (Blenders) | Sechristusa, SECHRIST 3500CP-G USER MANUAL Pdf Download | ManualsLib, SECHRIST 3500 SERIES USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023745 | Class II | Active |
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Manufacturer
- Manufacturer
- Sechrist Industries Inc
- FDA Applicant
- Sechrist Industries, Inc.
Sources (1)
- FDA 510(k) K023745 24 fields · synced Oct 1, 2026