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

• 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