Self-Cath Closed System

Basic Information

• Brand Name: Self-Cath Closed System
• Primary DI: 05708932279178
• Version / Model: 50264
• Catalog Number: 50264
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 5
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: b8d9bddf-9ab7-425c-8ce5-4f062ac00374

Device Description

Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 16, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932282932	GS1	Shipper Box	50	In Commercial Distribution
Primary	05708932279178	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070939	000
K223821	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	16	French
Catheter Working Length	31	Centimeter
Device Size Text, specify			Tip Type Straight/Nelaton
Catheter Working Length	12.2	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged and consult IFU.