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The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids, or tissue in any form. This device's target population is people who require insulin.

The Medicool Insulin Protector™ is a capsule-like portable container designed to transport insulin in a temperature controlled environment and protect it from environmental shock and other trauma. The Insulin Protector™ essentially consists of three main parts: the cooling tray, the foam insulation, and the outer casing. The cooling tray is a hollow-walled plastic container which has a cavity formed therein. The cooling tray is filled with water, which can be refrigerated in an ordinary household refrigerator. The cavity in the cooling tray receives up to two bottles of liquid insulin. The bottom and sides of the cavity include a plurality of ribbed members to prevent direct contact between the insulin bottles and the side walls of the cooling tray. The cooling tray fits inside the foam insulation snuggly to minimize heat transfer and loss, thus effectively stabilizing the inside temperature. This sleeve insulating foam is manufactured by Marko Foam and referenced as BI-99. The foam is flexible and helps provide protection from shock and trauma to the insulin bottles being stored in the cooling tray. The foam has cavities in both the top and bottom sections to receive the removable cooling tray. When the cooling tray is inserted into the cavity, a portion of the cooling tray extends above the surface of the foam. However, when the top section is closed, the cooling tray extends into the cavity of the top foam. The foam insulation containing the cooling tray fits snuggly inside the outer casing. The outer casing is stitched together using Cordura material, which is quality fabric known for its durability and resistance to abrasion. A zipper is used to open and close the main compartment that holds the foam insulation and the cooling tray. On the outside of the bag are two smaller pockets that close the cooling these pockets are designed to hold accessories, such as syringes, alcohol wipes, swabs, etc.

The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.