Wellead Male External Catheter

Basic Information

• Brand Name: Wellead Male External Catheter
• Primary DI: 06936881133503
• Version / Model: F03A032810
• Company Name: Well Lead Medical Co.,Ltd
• Labeler DUNS: 544811862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: 4b1a1eca-ca64-4ff5-994d-21780bcfae9e

Device Description

Type III 28mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61504	Penis wearable urinal	An externally-worn urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16936881133500	GS1	Box	30	In Commercial Distribution
Primary	06936881133503	GS1
Package	26936881133507	GS1	Carton	10	In Commercial Distribution