Theraplus

GUDID 00049696731621

Theraplus INFRARED FOREHEAD THERMOMETER

FOURSTAR GROUP INC.

Intermittent electronic patient thermometer

• Primary Device ID: 00049696731621
• NIH Device Record Key: 75b2a50a-9ca7-4118-84f5-e45f5a3b6638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Theraplus
• Version Model Number: 1
• Company DUNS: 656091279
• Company Name: FOURSTAR GROUP 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00049696731621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160802

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-02
• Device Publish Date: 2020-06-24

On-Brand Devices [Theraplus]

• 00049696731621: Theraplus INFRARED FOREHEAD THERMOMETER
• 00049696731379: Theraplus DIGITAL THERMOMETER
• 00049696738132: TheraPlus Digital thermometer
• 00049696739351: TheraPlus CHILDRENS CHARACTER THERMOMETER
• 00049696739795: TheraPlus CHILDRENS CHARACTER THERMOMETER