Silicone 2-way Foley Balloon Catheter (Standard Balloon)

Basic Information

• Brand Name: Silicone 2-way Foley Balloon Catheter (Standard Balloon)
• Primary DI: 04710961931898
• Version / Model: 1822-0516
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Labeler DUNS: 656763489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-03-11
• Public Version: 9
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: aaf3d0dc-7834-4c54-9ca5-98ab52cd806e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34917	Indwelling urethral drainage balloon catheter, non-antimicrobial	A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04710961931898	GS1
Unit of Use	14710961931895	GS1

Premarket Submissions

Submission Number	Supplement Number
K980919	000