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 ID00859290006014
NIH Device Record Keyb1def359-ed52-4ee8-becf-2251ed71a6f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruer Medical, Inc.
Version Model NumberES 12400
Catalog NumberES 12400
Company DUNS003530786
Company NameTRUER MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(714) 628-9785
Emailcpescador@truermedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859290006014 [Primary]
GS110859290006011 [Package]
Package: Carton [25 Units]
In Commercial Distribution
GS120859290006018 [Package]
Contains: 10859290006011
Package: Carton [2 Units]
In Commercial Distribution
GS130859290006015 [Package]
Contains: 20859290006018
Package: Carton [5 Units]
In Commercial Distribution
GS140859290006012 [Package]
Contains: 20859290006018
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZTStethoscope, Esophageal, With Electrical Conductors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-06

On-Brand Devices [Truer Medical, Inc.]

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

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