GEKKA

Basic Information

• Brand Name: GEKKA
• Primary DI: 06953825905279
• Version / Model: UFR101
• Company Name: Shenzhen Urion Technology Co., Ltd
• Labeler DUNS: 421294358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-10
• Public Version: 2
• Public Version Date: 2022-04-22
• Public Version Status: Update
• Public Device Record Key: 14cb5394-86be-435d-8e2b-0a14bb82e4dc

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58391	Medical device pressure monitor	A mechanical device designed to be connected to another device or system of devices (e.g., rectal suction biopsy system) to provide an accurate indication of the amount of negative pressure being applied in these devices during a surgical intervention or other procedure. It typically consists of a simple column that has incremented markings on its side(s) [e.g., in - cmH2O or - mmH2O], an indicator that shows the amount of negative pressure, and connectors for tubing that connect it to the operative device(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06953825905279	GS1

Premarket Submissions

Submission Number	Supplement Number
K200802	000