MedOne

GUDID 00864243000421

Forehead Thermometer

MEDONE LLC

Infrared patient thermometer, skin

• Primary Device ID: 00864243000421
• NIH Device Record Key: 97995f5f-b19f-4447-b421-789535bf23ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedOne
• Version Model Number: JPD-FR408
• Company DUNS: 080800987
• Company Name: MEDONE LLC
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864243000421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-21

On-Brand Devices [MedOne]

• 00864243000445: Blood Pressure Monitor
• 00864243000421: Forehead Thermometer
• 00864243000414: Fetal Heartbeat Monitor
• 00864243000407: Blood Pressure Monitor