Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more models

These devices are specifically designed for general hospital settings. The advisory committee classification under the FDA submission (General Hospital) confirms their intended use in environments where aseptic fluid transfer is critical, such as pharmacies, infusion centers, or procedural rooms where intravenous fluids and medications are prepared or administered.

These decanters are explicitly labeled as single-use only. The manufacturer emphasizes this in the description to ensure sterility and reduce contamination risk during clinical procedures, as reusing sterile medical devices can compromise their integrity and safety.

Since these devices are sterile, storage must follow standard sterile medical device protocols. They should be kept in their original packaging until ready for use, protected from moisture, physical damage, and contamination. Avoid exposing them to extreme temperatures or direct sunlight, as this could compromise their sterility.

The reference codes (e.g., 2000S for the C-Flo Bag Decanter) distinguish between the different models of the Microtek Medical decanter line. Each model is designed for specific applications—such as transferring fluids from bags, vials, or between containers—while maintaining sterility. The ‘S’ suffix indicates they are sterile, ensuring clarity for inventory and procurement.

These devices have undergone FDA 510(k) clearance (K251676) and comply with EU MDR regulations. The FDA’s clearance confirms they are substantially equivalent to a legally marketed predicate device, while MDR compliance ensures they meet stringent European safety and performance standards. Clinicians and buyers can rely on these pathways to validate their safety and suitability for aseptic fluid transfer in regulated healthcare settings.