BEWELL CONNECT

GUDID 03760165449362

VISIOMED GROUP

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 03760165449362
• NIH Device Record Key: 6d513435-25ce-4a8f-9391-c8ed696691a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEWELL CONNECT
• Version Model Number: BW-TSX
• 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: 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	03760165449362 [Primary]

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• 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