Tommee Tippee Digital Ear Thermometer

GUDID 50666519700012

Infrared digital ear thermometer used for measuring body temperature

MAYBORN USA, INC.

Infrared patient thermometer, ear

• Primary Device ID: 50666519700012
• NIH Device Record Key: 1617a708-60c7-4e55-96ec-0f36f593d569
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tommee Tippee Digital Ear Thermometer
• Version Model Number: TH889SE
• Company DUNS: 031274363
• Company Name: MAYBORN USA, INC.
• 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	50666519700012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020504

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-01

Devices Manufactured by MAYBORN USA, INC.

• 50666519700036 - Tommee Tippee Digital No Touch Thermomter: 2019-01-21 Tommee Tippee Digital No Touch Thermomter
• 50666519700012 - Tommee Tippee Digital Ear Thermometer: 2018-03-29Infrared digital ear thermometer used for measuring body temperature
• 50666519700012 - Tommee Tippee Digital Ear Thermometer: 2018-03-29 Infrared digital ear thermometer used for measuring body temperature