Truer Medical, Inc. ES 12400

GUDID 00859290006014

The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgical setting for monitoring temperature, as well as, heart and lung sounds of anesthetized patients. Inserted in the esophagus, the stethoscope provides an accurate measurement of core body temperature, as well as, transmitting clear heart and lung sounds to the anesthesiologist.

TRUER MEDICAL, INC.

Electronic oesophageal stethoscope, single-use

• Primary Device ID: 00859290006014
• NIH Device Record Key: b1def359-ed52-4ee8-becf-2251ed71a6f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truer Medical, Inc.
• Version Model Number: ES 12400
• Catalog Number: ES 12400
• 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: cpescador@truermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006014 [Primary]
GS1	10859290006011 [Package]; Package: Carton [25 Units]; In Commercial Distribution
GS1	20859290006018 [Package]; Contains: 10859290006011; Package: Carton [2 Units]; In Commercial Distribution
GS1	30859290006015 [Package]; Contains: 20859290006018; Package: Carton [5 Units]; In Commercial Distribution
GS1	40859290006012 [Package]; Contains: 20859290006018; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092716

FDA Product Code

• BZT: Stethoscope, Esophageal, With Electrical Conductors

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: 2016-06-06

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