Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)

Basic Information

• Brand Name: Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)
• Primary DI: 04710961934240
• Version / Model: 1890-8222
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Labeler DUNS: 656763489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-03-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0fd2b4b4-e785-4e84-a25b-ddb0e3778ae4

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
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	876.5090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34924	Suprapubic drainage catheter	A sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a male or female patient primarily for the drainage of urine, however it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube which may have one of a variety of hole/tip configurations at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04710961934240	GS1
Unit of Use	14710961934247	GS1

Premarket Submissions

Submission Number	Supplement Number
K014002	000