FGCCJP

GUDID 06953825904135

Shenzhen Urion Technology Co., Ltd

Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin

• Primary Device ID: 06953825904135
• NIH Device Record Key: f6f3f237-7bb1-445a-b31f-2cc9c8540e15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FGCCJP
• 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	06953825904135 [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: 2020-11-14

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825908277 - ALPHAMED: 2024-06-20
• 16953825908284 - ALPHAMED: 2024-06-20
• 16953825908291 - ALPHAMED: 2024-06-20
• 16953825908307 - ALPHAMED: 2024-06-20
• 16953825908215 - beebird: 2024-06-13
• 16953825908185 - Med One: 2024-05-31
• 16953825903494 - ALPHAMED: 2024-04-23 N/A
• 16953825908116 - N/A: 2024-04-23 N/A