GentleCath Hydrophilic Kit

Basic Information

• Brand Name: GentleCath Hydrophilic Kit
• Primary DI: 07333387044248
• Version / Model: 509015
• Catalog Number: 509015
• 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: 2024-11-25
• Public Version Status: Update
• Public Device Record Key: de6e93e0-9c65-454f-9941-deae781bb28a

Device Description

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 10FR

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
NWO	Kit, catheter, urinary (exludes HIV testing)	Gastroenterology, Urology	876.5130	2
LYZ	Vinyl patient examination glove	General Hospital	880.6250	1
EYY	Drape, urological, disposable	General, Plastic Surgery	878.4370	2
EZD	Catheter, straight	Gastroenterology, Urology	876.5130	2
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE	Gastroenterology, Urology	876.5250	1

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	07333387044255	GS1		10	In Commercial Distribution
Primary	07333387044248	GS1
Package	07333387044262	GS1		4	In Commercial Distribution
Previous	00768455142835	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	10	French
Length	16	Inch

Storage Conditions

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