MEDISANA 99652

GUDID 04015588987571

a hand-held, battery-powered, electronic instrument designed to measure :1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of the site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip.This device is intended for use in the home or healthcare facility. It is a reusable device

Medisana GmbH

Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin

• Primary Device ID: 04015588987571
• NIH Device Record Key: c643b9db-a226-4824-a66b-ccc718aae273
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDISANA
• Version Model Number: TM A75
• Catalog Number: 99652
• Company DUNS: 319241873
• Company Name: Medisana GmbH
• 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: true

Customer Support Contacts

• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us
• Phone: 2488633175
• Email: cservice@medisana.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015588987571 [Package]; Contains: 04015588996528; Package: cardboard [10 Units]; In Commercial Distribution
GS1	04015588996528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102554

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: 2021-07-15
• Device Publish Date: 2019-07-18

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