Silicone Y Drainage Tube

Basic Information

• Brand Name: Silicone Y Drainage Tube
• Primary DI: 04710961934448
• Version / Model: 1920-0016
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Labeler DUNS: 656763489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-03-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f4e926a0-4d11-481f-8f14-c784103ada33

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
GCA	Catheter, Biliary, Surgical	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11307	Biliary T drain	A sterile, T-shaped, tubular device designed to establish a channel for the removal of fluid from a body cavity or anatomical region (usually the biliary tract). It is typically used in conjunction with, or as a component of, a closed drainage system using a low negative pressure through the drain lumen. It is typically made of silicone and has perforations along its distal end; it does not include any fluid collection bags/containers. It comes in various shapes and sizes. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04710961934448	GS1
Unit of Use	14710961934445	GS1

Premarket Submissions

Submission Number	Supplement Number
K980917	000