belter

GUDID 16947468500011

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

Infrared patient thermometer, ear

• Primary Device ID: 16947468500011
• NIH Device Record Key: 9c51e6b4-d6a1-482d-8fe6-16a35c4d6449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: belter
• Version Model Number: TE-91
• 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	06947468500014 [Primary]
GS1	16947468500011 [Package]; Contains: 06947468500014; Package: pcs/box [1 Units]; In Commercial Distribution
GS1	26947468500018 [Package]; Package: pcs/box [60 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: 2020-05-11
• Device Publish Date: 2020-05-02

On-Brand Devices [belter]

• 26947468500384: SF-371
• 16947468500011: TE-91
• 16947468500042: TE-93
• 16947468500080: Blood Pressure Meter
• 06947468500373: Body temperature