Dovideq LeakControl Device

Basic Information

• Brand Name: Dovideq LeakControl Device
• Primary DI: 00816185001127
• Version / Model: T11-ASY-LEAKCONTROL
• Catalog Number: T11-ASY-LEAKCONTROL
• Company Name: Torvan Medical Inc
• Labeler DUNS: 200280404
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-18
• Public Version: 1
• Public Version Date: 2025-09-26
• Public Version Status: New
• Public Device Record Key: d96cc5f3-8780-4958-8b10-a41d7f29bef2

Device Description

The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37006	Invasive medical device leak tester, electrical	An electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816185001127	GS1