CAREGIVER PROFESSIONAL CLINICAL THERMOMETER

GUDID 00852119002051

THERMOMEDICS, INC.

Infrared patient thermometer, skin

• Primary Device ID: 00852119002051
• NIH Device Record Key: 379c74a9-7044-4478-93ea-b5f52fb10f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAREGIVER PROFESSIONAL CLINICAL THERMOMETER
• Version Model Number: PRO-TF300
• Company DUNS: 013209138
• Company Name: THERMOMEDICS, 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: true
• 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	00852119002051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131771

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: 2018-03-29
• Device Publish Date: 2017-03-21