Clear Advantage Male Continence Sheath

Basic Information

• Brand Name: Clear Advantage Male Continence Sheath
• Primary DI: 00801741070846
• Version / Model: 3363NHS
• Catalog Number: 3363NHS
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 601b3427-d994-47dc-ae97-0983151e26ee

Device Description

Clear Advantage with Aloe Clear Silicone Self-Adhesive Male Continence Sheath

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: Yes
• 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
NNX	DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34929	Urinary incontinence penis sheath/port, single-use	A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. 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	10801741070843	GS1	CA	5	In Commercial Distribution
Primary	00801741070846	GS1
Package	20801741070840	GS1	CA	100	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	36	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature