Truer Medical, Inc. TP 400

GUDID 30859290006145

The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Truer Medical, Inc. Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps.

TRUER MEDICAL, INC.

Infrared patient thermometer, skin

• Primary Device ID: 30859290006145
• NIH Device Record Key: 5619baaa-0db5-4f7e-ac7c-12c9be27e47b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truer Medical, Inc.
• Version Model Number: TP 400
• Catalog Number: TP 400
• Company DUNS: 003530786
• Company Name: TRUER MEDICAL, 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com
• Phone: (714) 628-9785
• Email: ttruitt@truermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006144 [Primary]
GS1	10859290006141 [Package]; Contains: 00859290006144; Package: Carton [50 Units]; In Commercial Distribution
GS1	20859290006148 [Package]; Contains: 10859290006141; Package: Carton [4 Units]; In Commercial Distribution
GS1	30859290006145 [Package]; Contains: 10859290006141; Package: Carton [6 Units]; In Commercial Distribution
GS1	40859290006142 [Package]; Contains: 10859290006141; Package: Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101244

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: 2016-08-04

On-Brand Devices [Truer Medical, Inc.]

• 30859290006145: The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface
• 40859290006135: The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface
• 00859290006120: Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes
• 00859290006113: Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes
• 00859290006106: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006090: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006083: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006076: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006069: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006052: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006045: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006038: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006021: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006014: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006007: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica