Thermometer

GUDID 26947468554660

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

Infrared patient thermometer, ear

• Primary Device ID: 26947468554660
• NIH Device Record Key: 5ddce3b6-8656-4719-8a5a-4fc6c593abc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermometer
• Version Model Number: EQ-HW-TH-100-PD
• 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	06947468554666 [Primary]
GS1	16947468554663 [Package]; Contains: 06947468554666; Package: 1pcs/box [1 Units]; In Commercial Distribution
GS1	26947468554660 [Package]; Contains: 16947468554663; Package: 12pcs/box [12 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: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [Thermometer]

• 26947468554639: EQ-HW-TH-150-DI
• 26947468554622: EQ-HW-TH-100-PD
• 26947468554653: EQ-HW-TH-150-DI
• 06947468554642: EQ-HW-TH-100-PD
• 26947468554660: EQ-HW-TH-100-PD