TRUE INTEGRAL

GUDID 00860001532746

Dual mode thermometer

TRUE INTEGRAL INC

Infrared patient thermometer, skin

• Primary Device ID: 00860001532746
• NIH Device Record Key: 657bcc8f-6d5a-4c61-99e1-0e8c0c313632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE INTEGRAL
• Version Model Number: dual mode thermometer FC-IR1010
• Company DUNS: 117033737
• Company Name: TRUE INTEGRAL 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: true
• 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	00860001532746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181215

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: 2019-05-02
• Device Publish Date: 2019-04-24

On-Brand Devices [TRUE INTEGRAL]

• 00860001532760: Upper Arm Blood Pressure Monitor
• 00860001532753: Digital thermometer
• 00860001532746: Dual mode thermometer
• 00860001532739: B02
• 00860001532708: B05
• 00860001532777: Digital thermometer
• 00860003079706: Intelligent Mesh Nebulizer
• 00860003079737: UPER ARM BLOOD PRESSURE MONITOR
• 00860003079713: INFRARED FOREHEAD THERMOMETER
• 00860003079744: UPER ARM BLOOD PRESSURE MONITOR
• 00860003079720: No- contact infarared body thermometer