THERMOFLASH

GUDID 03760165447474

VISIOMED GROUP

Infrared patient thermometer, skin

• Primary Device ID: 03760165447474
• NIH Device Record Key: eeca8c76-e2d6-4923-ad68-5b1b06f0dc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERMOFLASH
• Version Model Number: LX-26E TONIC MAGENTA
• 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	03760165447474 [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: false

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

On-Brand Devices [THERMOFLASH]

• 03760165449843: LX-26E ARTIC LIME
• 03760165449836: LX-26E PINK
• 03760165449492: LX-26E GREEN
• 03760165449485: LX-26E LIGHT BLUE
• 03760165449478: LX-26E OCEAN BLUE
• 03760165448259: LX-261E
• 03760165448242: LX-260TE
• 03760165447481: LX-26E TONIC ANIS
• 03760165447474: LX-26E TONIC MAGENTA
• 03760165447467: LX-26E TONIC BLUE
• 03760165447429: LX-26E WHITE
• 03760165446408: LX-361T
• 03700609705142: LX-26E POP GREEN
• 03700609705135: LX-26E POP BLUE
• 03700609705128: LX-26E POP PINK
• 03700609705111: LX-26E VINYL PINK
• 03700609705104: LX-26E VINYL GREEN
• 03700609705098: LX-26E VINYL BLEU