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 ID30859290006145
NIH Device Record Key5619baaa-0db5-4f7e-ac7c-12c9be27e47b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruer Medical, Inc.
Version Model NumberTP 400
Catalog NumberTP 400
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
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com
Phone(714) 628-9785
Emailttruitt@truermedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859290006144 [Primary]
GS110859290006141 [Package]
Contains: 00859290006144
Package: Carton [50 Units]
In Commercial Distribution
GS120859290006148 [Package]
Contains: 10859290006141
Package: Carton [4 Units]
In Commercial Distribution
GS130859290006145 [Package]
Contains: 10859290006141
Package: Carton [6 Units]
In Commercial Distribution
GS140859290006142 [Package]
Contains: 10859290006141
Package: Carton [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

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 Date2016-08-04

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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