Truer Medical, Inc.

Basic Information

• Brand Name: Truer Medical, Inc.
• Primary DI: 00859290006045
• Version / Model: ES 12400H
• Catalog Number: ES 12400H
• Company Name: TRUER MEDICAL, INC.
• Labeler DUNS: 003530786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7158c59f-60c2-486c-8f90-10720cb5f1a1

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	868.1920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44120	Electronic oesophageal stethoscope, single-use	An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859290006045	GS1
Package	40859290006043	GS1	Carton	6	In Commercial Distribution
Package	30859290006046	GS1	Carton	5	In Commercial Distribution
Package	20859290006049	GS1	Carton	2	In Commercial Distribution
Package	10859290006042	GS1	Carton	25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092716	000