Mothermed

GUDID 10818218021024

This product is suitable for measuring temperature of the human ear.

Famidoc Technology Co.,Ltd.

Infrared patient thermometer, ear Infrared patient thermometer, ear

• Primary Device ID: 10818218021024
• NIH Device Record Key: fd1c91dd-76ae-4b02-81e4-fc353588bbb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mothermed
• Version Model Number: IR102
• 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	00818218021027 [Primary]
GS1	10818218021024 [Package]; Contains: 00818218021027; Package: BOX [40 Units]; In Commercial Distribution

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: 2016-11-25

On-Brand Devices [Mothermed]

• 10818218029037: Self-adhesive Electrode
• 00818218029009: Self-adhesive Electrode
• 00818218027029: Metal Comb
• 00818218027012: Electronic Lice Comb
• 00818218024080: To be used for temporary relief of pain associated with sore and aching muscles due to strain fr
• 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