Mothermed

GUDID 00818218020112

This thermometer is intended for non-contact to measurement of forehead temperature at home or hospital for anyone,forehead temperature measurement is suitable for the human body, can also be used to measure surface temperature.

Famidoc Technology Co.,Ltd.

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• Primary Device ID: 00818218020112
• NIH Device Record Key: a2771f87-303c-4588-bc7a-502ad79c9c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mothermed
• Version Model Number: IR110
• Company DUNS: 421343701
• Company Name: Famidoc Technology Co.,Ltd.
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818218020112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113761

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: 2017-01-05

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• 00818218024073: Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdo
• 10818218024056: The product is suitable to be used for temporary relief of pain associated with sore and aching
• 00818218021225: This thermometer is intended for non-contact to measurement of forehead temperature at home or h
• 10818218021024: This product is suitable for measuring temperature of the human ear.
• 00818218020242: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 00818218020112: This thermometer is intended for non-contact to measurement of forehead temperature at home or h