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The Medical Products, Inc. Controlled Temperature Cabinet Systems are designed to store and maintain the temperature of drugs and I.V. solutions in the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC.

The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 210 to 26°C and for I.V. solutions the temperature range is 35°co 40°C.

Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.

Controlled Temperature Cabinet System

This document is a 510(k) premarket notification approval letter for a Controlled Temperature Cabinet System, and therefore does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was approved based on its substantial equivalence to a legally marketed predicate device, and not on a new study demonstrating its efficacy or performance against specific acceptance criteria.

The "Indications for Use" section on page 3 describes what the device is designed to do (store drugs and IV solutions within specific temperature ranges in an ambulance or mobile vehicle), but it does not provide performance metrics or acceptance criteria for those functions.

Therefore, I cannot provide the requested information from the given text.

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