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The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.

The All-In-One® Two Chamber Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. It is an empty single use, disposable I.V. container that is vertically divided into two chambers. The left chamber is intended to store lipid emulsions. The right chamber is intended to store amino acid/dextrose admixtures. Additives may be added via the non-latex medication injection port located at the bottom of the left chamber. The chambers are designed to be filled with a total parenteral nutrition (TPN) solution by a pharmacy operation.

The contents of the container are intended to be stored with the seal intact (i.e., not broken) until the time of use (administration to the patient).

At the time of use, the contents of the two chambers are combined/mixed by opening the vertical peel-seal that runs along the inside of the container. The mixed contents of the container are then dispensed to the patient though a secondary administration set (i.e., a separate medical device that is not the subject of this submission).

This document does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a 510(k) summary for a medical device (All-In-One Two Chamber Container) which describes its intended use and states that non-clinical tests demonstrate acceptable performance, but does not provide details about the specific tests, acceptance criteria, or their results. It also confirms that the device is substantially equivalent to a predicate device.

Therefore, I cannot provide the requested information.

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