GentleCath Hydrophilic Kit

Basic Information

• Brand Name: GentleCath Hydrophilic Kit
• Primary DI: 07333387044361
• Version / Model: 509019
• Catalog Number: 509019
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-01
• Public Version: 4
• Public Version Date: 2024-11-28
• Public Version Status: Update
• Public Device Record Key: 5e6e0ade-e884-401a-9db3-c7a6359219a9

Device Description

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 18FR

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
EZD	Catheter, straight	Gastroenterology, Urology	876.5130	2
LYZ	Vinyl patient examination glove	General Hospital	880.6250	1
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE	Gastroenterology, Urology	876.5250	1
EYY	Drape, urological, disposable	General, Plastic Surgery	878.4370	2
NWO	Kit, catheter, urinary (exludes HIV testing)	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	07333387044385	GS1		4	In Commercial Distribution
Package	07333387044378	GS1		10	In Commercial Distribution
Primary	07333387044361	GS1
Previous	00768455142873	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	18	French
Length	16	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry