SMARTRO

GUDID 06926347911615

EFT-161 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode,and ear temperature mode. The measurement result directly shows on the LCD screen, It is easy, hygiene and accurate. The device is widely used for home healthcare, medical institutes and many other occasions.

Shenzhen Brav Electronic Technologies Co., Ltd.

Infrared patient thermometer, ear

• Primary Device ID: 06926347911615
• NIH Device Record Key: ff70880d-f43d-4379-bc35-5ffd62e90fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTRO
• Version Model Number: EFT-161
• Company DUNS: 421279648
• Company Name: Shenzhen Brav Electronic Technologies 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06926347911615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171214

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: 2019-05-16
• Device Publish Date: 2019-05-08

Devices Manufactured by Shenzhen Brav Electronic Technologies Co., Ltd.

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