Braun

GUDID 10328785000051

Braun Infrared ThermoScan Ear Thermometer - for intermittent measurement of temperature for patients of all ages, this thermometer is used with lens filters.

KAZ, INC.

Infrared patient thermometer, ear

• Primary Device ID: 10328785000051
• NIH Device Record Key: a2a790bf-ed69-4921-aeb4-f6456b1fdb2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Braun
• Version Model Number: IRT6500US
• Company DUNS: 001483890
• Company Name: KAZ, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: 1-800-327-7226
• Email: consumerrelations@kaz.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00328785000054 [Primary]
GS1	10328785000051 [Package]; Contains: 00328785000054; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103800

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: 2016-09-09

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