Bluedot

GUDID 16947468500325

Shenzhen Belter Health Measurement and Analysis 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 Infrared patient thermometer, skin

• Primary Device ID: 16947468500325
• NIH Device Record Key: b098931b-a71f-4be2-b866-cfe6ea9262bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bluedot
• Version Model Number: TE-79
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947468500441 [Primary]
GS1	16947468500325 [Package]; Contains: 06947468500441; Package: [1 Units]; In Commercial Distribution
GS1	26947468500339 [Package]; Package: [20 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: 2023-04-06
• Device Publish Date: 2023-03-29

Devices Manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

• 16947468500363 - RITE AID: 2023-09-28
• 16947468500356 - Bytech: 2023-07-04
• 16947468500349 - RITE AID: 2023-06-05
• 16947468500332 - NO: 2023-05-31
• 16947468500325 - Bluedot: 2023-04-06
• 16947468500325 - Bluedot: 2023-04-06
• 16947468500318 - CARE TOUCH: 2022-11-22
• 16947468500295 - biotricity: 2022-08-26
• 16947468500301 - biotricity: 2022-08-26