Medical/Surface Thermometer

GUDID 00840177900006

MASTERCOOL, U.S.A., INC.

Infrared patient thermometer, skin

• Primary Device ID: 00840177900006
• NIH Device Record Key: a8cd9bcb-35e8-4fd1-b421-2c65e09adbc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical/Surface Thermometer
• Version Model Number: 52225-MED
• Company DUNS: 108662602
• Company Name: MASTERCOOL, U.S.A., 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840177900006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121428

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: 2020-12-04
• Device Publish Date: 2020-06-17