Positioning System

Basic Information

• Brand Name: Positioning System
• Primary DI: 07290016936247
• Version / Model: FPRMC00036
• Catalog Number: FPRMC00036
• Company Name: UC-CARE LTD
• Labeler DUNS: 649551124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-15
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 12f5eab5-60e4-4e9a-92c0-569cfbc853e5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63012	Urinary catheter holder, sterile	A sterile device designed to be attached to a patient's body to hold an indwelling urinary catheter (e.g., Foley, ureteral), or a tube attached to it, in place. It typically consists of a wrap placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook/loop closure, spring tensioner) without creating excessive pressure on it and permitting visual inspection of the site. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016936247	GS1

Premarket Submissions

Submission Number	Supplement Number
K082919	000