Bytech

GUDID 16974239700592

Guangzhou Daxin health 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 Infrared patient thermometer, skin

• Primary Device ID: 16974239700592
• NIH Device Record Key: 7e746695-9479-45f2-84f5-fe8f919a58c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bytech
• Version Model Number: TE-90
• Company DUNS: 722481840
• Company Name: Guangzhou Daxin health 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974239702803 [Primary]
GS1	16974239700592 [Package]; Contains: 06974239702803; Package: [1 Units]; Discontinued: 2023-11-14; Not in Commercial Distribution
GS1	26974239700599 [Package]; Package: [12 Units]; Discontinued: 2023-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140681

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: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Bytech]

• 16974239700592: TE-90
• 16974239700608: T30-BEE
• 16974239700615: T30-BEE