PORTAL724

GUDID 06947468500175

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

Infrared patient thermometer, skin

• Primary Device ID: 06947468500175
• NIH Device Record Key: 58a203ab-3946-476e-b3f0-cdb3de001602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTAL724
• 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	06947468500175 [Primary]

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: 2021-04-29
• Device Publish Date: 2021-04-21

On-Brand Devices [PORTAL724]

• 06947468500175: TE-91
• 06947468500168: EPA-13B4