JZIKI Infrared Forehead Themometer

GUDID 06922119300113

The Infrared forehead thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

ShenZhen ZhengKang Technology Co., Ltd.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 06922119300113
• NIH Device Record Key: b7ef6623-2c7e-4615-ae99-22d80f1fc09f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JZIKI Infrared Forehead Themometer
• Version Model Number: JZK-601
• Company DUNS: 530875902
• Company Name: ShenZhen ZhengKang 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: false
• 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	06922119300113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203707

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-17
• Device Publish Date: 2021-05-07

On-Brand Devices [JZIKI Infrared Forehead Themometer]

• 06922119300175: The Infrared forehead thermometer is a non-contact infrared thermometer intended for the intermi
• 06922119300168: The Infrared forehead thermometer is a non-contact infrared thermometer intended for the intermi
• 06922119300113: The Infrared forehead thermometer is a non-contact infrared thermometer intended for the intermi