Bytech

GUDID 16947468554779

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Infrared patient thermometer, ear

• Primary Device ID: 16947468554779
• NIH Device Record Key: df99353d-7f01-4dba-8847-47662aab2882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bytech
• Version Model Number: EQ-HW-TH-150-DI
• Company DUNS: 529903321
• Company Name: Shenzhen Belter Health Measurement and Analysis 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	06947468554772 [Primary]
GS1	16947468554779 [Package]; Contains: 06947468554772; Package: 1pcs/box [1 Units]; In Commercial Distribution
GS1	26947468554776 [Package]; Package: 12pcs/box [1 Units]; 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: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [Bytech]

• 26947468554677: EQ-HW-TH-150-DI
• 16947468554786: EQ-HW-TH-150-DI
• 16947468554779: EQ-HW-TH-150-DI
• 26947468554721: EQ-HW-TH-150-DI
• 26947468554714: EQ-HW-TH-150-DI
• 16947468500356: T30-BEE