GEKKA

GUDID 06953825904098

Shenzhen Urion Technology Co., Ltd

Infrared patient thermometer, ear/skin

• Primary Device ID: 06953825904098
• NIH Device Record Key: b82cc271-5868-4c6f-8086-5b8b12ff6024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEKKA
• Version Model Number: UFR101
• Company DUNS: 421294358
• Company Name: Shenzhen Urion Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825904098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200802

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-22
• Device Publish Date: 2020-11-06

On-Brand Devices [GEKKA]

• 06953825905279: UFR101
• 06953825904098: UFR101