PureWick Female External Catheter

Basic Information

• Brand Name: PureWick Female External Catheter
• Primary DI: 00801741215933
• Version / Model: PWFX30L
• Catalog Number: PWFX30L
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 1
• Public Version Date: 2020-12-23
• Public Version Status: New
• Public Device Record Key: 4c68bb6c-7eb6-4866-876a-7fb2596a2817

Device Description

PureWick Female External Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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	20801741215937	GS1	BX	6	In Commercial Distribution
Package	10801741215930	GS1	CA	30	In Commercial Distribution
Primary	00801741215933	GS1

Customer Contacts

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