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The EZ-Protect™ Hydrophilic Closed System Intermittent Catheter is intended to drain urine from the bladder.

The EZ-Protect Hydrophilic Closed System Intermittent Catheters and EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits are sterile, closed system, single use, disposable, hydrophilic coated PVC catheter with either a straight or coude tip, self-contained along with a water sachet pouch to activate the hydrophilic coating and a collection bag. The EZ-Protect Hydrophilic Closed System Intermittent Catheters and EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits are used to drain urine from the bladder. The EZ-Protect Hydrophilic Closed System Intermittent Catheters are 16 inches in length and in sizes from 8 Fr. to 18 Fr. The EZ-Protect Hydrophilic Closed System Intermittent Catheters are designed with the collection bag and introducer tip allowing the user to insert the catheter without having to touch the catheter.

The EZ-Protect Hydrophilic Closed System Intermittent Catheter Kit consists of components used to drain urine from the bladder. The EZ-Protect Hydrophilic Closed System Intermittent Catheter Kit contains the sterile EZ-Protect Hydrophilic Closed System Intermittent Catheter (subject of this submission) along with the following Class I, exempt devices: gauze pad, Benzalkonium Chloride (BZK) swab/wipe, gloves, underpad and privacy disposal. The kit components are purchased, off the shelf by the kit packager Hangzhou Jimushi Medical CO., LTD. (Uricare). These components are similar to those provided in predicate device Rusch Hydrophilic Intermittent catheters (K183461) and reference device MTG Instant Cath (K080878).

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