CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231414 FDA 510(k)
- FDA Product Code
- DTZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4350 FDA 510(k)
- Regulation Number
- 870.4350 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CMO8 Adult PMP Oxygenator with Tubing Pack is a hollow fiber membrane oxygenator designed for physiologic gas exchange in adults and small adults during cardiopulmonary procedures. It incorporates a PMP long-term membrane to facilitate efficient oxygenation and carbon dioxide removal, supporting extracorporeal life support (ECLS) applications.
This device is supplied as a single-use system, including integrated tubing, and is intended for use in controlled clinical environments such as operating rooms or intensive care units. Authorized under FDA 510(k) clearance and MDR compliance, it adheres to Class II regulatory standards for cardiopulmonary bypass devices. Proper storage and handling per manufacturer instructions are required to maintain sterility and performance.
Frequently asked questions
What clinical procedures is this oxygenator designed to support during adult cardiopulmonary interventions?
The CMO8 Adult PMP Oxygenator with Tubing Pack is specifically engineered for physiologic gas exchange in adults and small adults during cardiopulmonary procedures, including extracorporeal life support (ECLS) applications. Its PMP long-term membrane enhances oxygenation and carbon dioxide removal, making it suitable for extended support in controlled environments like operating rooms or intensive care units.
Is this device intended for single-use or can it be reused after sterilization?
This device is explicitly supplied as a single-use system, including integrated tubing. Reuse is not authorized or recommended, as it could compromise sterility, performance, or patient safety. Proper adherence to manufacturer instructions for single-use handling is required.
How should the oxygenator be stored to ensure sterility and functionality?
The CMO8 Adult PMP Oxygenator must be stored according to the manufacturer’s guidelines to preserve sterility and performance. Since it is a single-use device, it should remain in its sealed packaging until immediately before use, protected from contamination, moisture, and physical damage. Avoid exposure to extreme temperatures or direct sunlight.
What regulatory pathways does this device follow, and what does that mean for its use?
The device is authorized under FDA 510(k) clearance and MDR compliance, classifying it as a Class II medical device for cardiopulmonary bypass applications. This means it has undergone regulatory review to demonstrate substantial equivalence to predicate devices and meets EU safety, performance, and clinical requirements. Clinicians should confirm local regulatory compliance before use.
Are there different sizes or models available for this oxygenator, or is this a fixed configuration?
This entry describes a single model (CME40009) of the CMO8 Adult PMP Oxygenator, which is designed for adult and small adult patients. While the specifications do not list alternative sizes, the manufacturer may offer variations for pediatric use under separate models or registrations. Always verify the correct model for your patient population.
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: PDF Designed for Performance and Endurance., CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (K231414 ..., CM08 Oxygenator by Chalice Medical - Med Alliance International
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231414 | Class II | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- FDA Applicant
- Chalice Medical , Ltd.
Sources (2)
- FDA 510(k) K231414 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026