Product Information

Product and Regulatory Information

This page provides product identification, regulatory and manufacturer information for external urine collection catheters sold on Yowelcom.com.

Products

  • Female External Catheter - 30 Count
  • Yowelcom Male External Catheter - 30 Count

Both products are supplied non-sterile, are intended for single use, are individually sealed, and are not made with natural rubber latex.

Intended System Configuration

These external catheters are intended for use with a compatible powered (suction) urine collection system. The powered collection system, canister, and tubing are not included with either 30-count carton.

FDA Information

Classification name Collector, Urine, Powered, Non Indwelling Catheter
Device class Class I
Product code NZU
Regulation number 21 CFR 876.5250
Premarket notification 510(k) exempt

A 510(k) exemption does not mean that the product is unregulated. Applicable establishment registration, device listing, labeling, reporting, and other regulatory requirements continue to apply.

Manufacturer

Foshan Haiseer Electronic Technology Co., Ltd.
FDA registration number: 3043729119
Country of manufacture: China

Operating Entity

PASCAL TECHNOLOGY (HONG KONG) LIMITED
Hong Kong company registration number: 76853645-000-07-25-2
Room 1804, 18/F, Alliance Building,
133 Connaught Road Central, Sheung Wan, Hong Kong

U.S. Returns and Business Correspondence

U.S. returns and business correspondence address
14950 Valley View Ave
La Mirada, CA 90638
United States

Email: support@yowelcom.com

For complete directions, warnings, and precautions, read the applicable Instructions for Use before using the product.