Zoe+Ruth Non-contact Infrared Thermometer

GUDID 00863850000305

ZOE RUTH

Infrared patient thermometer, skin

• Primary Device ID: 00863850000305
• NIH Device Record Key: fcb0e641-c794-40a2-8e3c-90317b2b26fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zoe+Ruth Non-contact Infrared Thermometer
• Version Model Number: ZR-IR200
• Company DUNS: 744277563
• Company Name: ZOE RUTH
• 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	00863850000305 [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: 2016-09-25

Devices Manufactured by ZOE RUTH

• 00863850000329 - Zoe+Ruth Forehead and Ear - Object Digital Thermometer: 2020-04-27
• 00863850000305 - Zoe+Ruth Non-contact Infrared Thermometer: 2018-07-06
• 00863850000305 - Zoe+Ruth Non-contact Infrared Thermometer: 2018-07-06