Bytech

GUDID 16974239700592

Guangzhou Daxin health technology Co.,Ltd

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