UniTip Catheter

Basic Information

• Brand Name: UniTip Catheter
• Primary DI: 07640172972175
• Version / Model: K8200-L4-0217-D
• Company Name: Unisensor AG
• Labeler DUNS: 483298907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7b77404c-08e8-44a7-a9c1-3d2c6e1b849b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEN	DEVICE, CYSTOMETRIC, HYDRAULIC	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62245	Urodynamic manometric catheter, electronic, reusable	A non-sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may in addition have impedance electrodes and/or a lumen to fill/drain the bladder to facilitate pressure measurement. This is a reusable device intended to be sterilized/cleaned prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640172972175	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French