All Silicone Foley Catheter with Temperature Sensor

Basic Information

• Brand Name: All Silicone Foley Catheter with Temperature Sensor
• Primary DI: 06944932785793
• Version / Model: F01C011605
• Company Name: Well Lead Medical Co.,Ltd
• Labeler DUNS: 544811862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-05
• Public Version: 1
• Public Version Date: 2025-02-13
• Public Version Status: New
• Public Device Record Key: 61a56a3c-4f55-4d3a-9ea7-1d3a35ced661

Device Description

2-way Standard 16Fr 5-10mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• 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
46629	Temperature-monitoring indwelling urethral drainage catheter	A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16944932785790	GS1	Box	10	In Commercial Distribution
Primary	06944932785793	GS1
Package	26944932785797	GS1	Carton	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K202134	000