BEWELL CONNECT MyThermo

GUDID 03760165440291

VISIOMED GROUP

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: 03760165440291
• NIH Device Record Key: b0d536a6-a26b-4715-a705-70d1c6105e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEWELL CONNECT MyThermo
• Version Model Number: BW-CX10
• Company DUNS: 261118805
• Company Name: VISIOMED GROUP
• 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: true
• 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	03760165440291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160816

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-04
• Device Publish Date: 2017-04-28

Devices Manufactured by VISIOMED GROUP

• 03760165448167 - BEWELL CONNECT MyOxy: 2021-11-10
• 03700609705098 - THERMOFLASH: 2020-12-04
• 03700609705104 - THERMOFLASH: 2020-12-04
• 03700609705111 - THERMOFLASH: 2020-12-04
• 03700609705128 - THERMOFLASH: 2020-12-04
• 03700609705135 - THERMOFLASH: 2020-12-04
• 03700609705142 - THERMOFLASH: 2020-12-04
• 03760165440291 - BEWELL CONNECT MyThermo: 2020-12-04
• 03760165440291 - BEWELL CONNECT MyThermo: 2020-12-04