class-ii-medical-device Downloads
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The Nephros S100 Sink Spout Filter purifies EPA-quality water and makes it suitable for drinking, the washing of a surgeon’s hands, and cleaning of medical equipment. This model type is a point-of-use microfilter capable of retaining bacteria for 90 days and ideal for emergency use. The S100 Sink Spout Filter is FDA 510(k)-cleared as a Class ...
Codonics Safe Label System SLS 550i Point of Care Station (PCS) is the standard of care in the world’s leading hospitals. An award-winning FDA Class II medical device, the system improves the safety and accuracy of medication management and labeling compliance anywhere medications are prepared. In the OR, SLS integrates with anesthesia drug carts (ADCs) to electronically identify the drug ...
ByCodonics
The Nephros DSU-H Ultrafilter purifies EPA-quality water and makes it suitable for drinking, wound cleansing, surgical handwashing, and medical equipment cleaning. This model type is an in-line filter capable of retaining bacteria, viruses, and endotoxins for 180 days and ideal for proactive water management. The DSU-H Ultrafilter is FDA 510(k)-cleared as a Class II medical ...
The Nephros SSU-H Ultrafilter purifies EPA-quality water and makes it suitable for drinking, wound cleansing, surgical handwashing, and medical equipment cleaning. This model type is an in-line filter capable of retaining bacteria, viruses, and endotoxins for 90 days and ideal for proactive water management. The SSU-H Ultrafilter is FDA 510(k)-cleared as a Class II medical ...
Definition of the medical device and intended useAs a manufacturer, you determine theintended use of your device. ...