Argyle Pediatric Urine Collector

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K813479 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →

• What is the Argyle Pediatric Urine Collector used for?

  The Argyle Pediatric Urine Collector is specifically designed for pediatric patients to safely and hygienically collect urine from indwelling catheters. It minimizes the risk of contamination and leakage, ensuring secure attachment to the catheter while maintaining patient comfort. This makes it ideal for clinical settings like hospitals, pediatric clinics, and home healthcare environments.

• Is the Argyle Pediatric Urine Collector sterile and single-use?

  Yes, the Argyle Pediatric Urine Collector is supplied as a sterile, single-use product. This ensures patient safety by preventing cross-contamination between uses and adheres to standard medical device handling guidelines for maintaining sterility until use.

• What sizes or models are available for the Argyle Pediatric Urine Collector?

  The Argyle Pediatric Urine Collector is specifically designed to accommodate smaller pediatric sizes, ensuring a secure and comfortable fit for children. While exact model variations are not detailed in the provided data, the device is tailored to pediatric needs, distinguishing it from adult-sized urine collectors.

• How should the Argyle Pediatric Urine Collector be stored?

  To maintain sterility, the Argyle Pediatric Urine Collector must be stored according to standard medical device handling guidelines. This includes keeping the packaging intact and ensuring it is protected from contamination until the time of use. Always follow facility protocols for proper storage and handling.

• Is the Argyle Pediatric Urine Collector safe for use in MRI environments?

  The Argyle Pediatric Urine Collector is non-magnetic and labeled as MRI-safe. However, specific MRI compatibility should always be confirmed with the facility’s protocols before use, as individual MRI systems may have varying safety requirements.