THERMOFLASH

GUDID 03700609705098

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: 03700609705098
• NIH Device Record Key: b5735fa6-55f4-45e9-b4c4-04117e9dc033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERMOFLASH
• Version Model Number: LX-26E VINYL BLEU
• 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	03700609705098 [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