Surity Female External Catheter

Basic Information

• Brand Name: Surity Female External Catheter
• Primary DI: 07333387056630
• Version / Model: 38011
• Catalog Number: 3801140
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 3
• Public Version Date: 2026-04-03
• Public Version Status: Update
• Public Device Record Key: 7e25f950-983f-4fad-8599-ffdb40b26866

Device Description

Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZU	Collector, urine, powered, non indwelling catheter	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61157	Female wearable urinal, single-use	A non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. 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	07333387055329	GS1		30	In Commercial Distribution
Primary	07333387056630	GS1
Package	07333387056838	GS1		3	In Commercial Distribution
Package	07333387056821	GS1		16	In Commercial Distribution
Package	07333387055312	GS1		3	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the products in room temperature, 60-77°F