Zoe+Ruth Forehead and Ear - Object Digital Thermometer

GUDID 00863850000329

ZOE RUTH

Infrared patient thermometer, ear

• Primary Device ID: 00863850000329
• NIH Device Record Key: 64228d00-6de8-4b23-86c5-f8f6121a03dd
• Commercial Distribution Discontinuation: 2025-11-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zoe+Ruth Forehead and Ear - Object Digital Thermometer
• Version Model Number: ZR-FE501
• Company DUNS: 744277563
• Company Name: ZOE RUTH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 1 503 928 7884
• Email: customerservice@zoeruth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863850000329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182133

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: 2020-04-27
• Device Publish Date: 2019-11-23

Devices Manufactured by ZOE RUTH

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