Gel warmer

Basic Information

• Brand Name: Gel warmer
• Primary DI: 06971355420796
• Version / Model: UGW-01
• Company Name: SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
• Labeler DUNS: 543063066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-31
• Public Version: 1
• Public Version Date: 2021-11-08
• Public Version Status: New
• Public Device Record Key: 8da312ba-a96c-462b-960d-552b0dc593f4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17506	Gel warmer	A portable, mains electricity (AC-powered) device intended to be used to prewarm gels (e.g., ultrasonic coupling gels, vaginal exploratory gels) prior to patient application. It is typically a tabletop device that includes a recess or a well for placement of a gel container, a heating element, a thermostat, and operating controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971355420796	GS1

Premarket Submissions

Submission Number	Supplement Number
K210154	000