TempTraq 601

GUDID 00851203006012

Continuous Temperature Monitor

BLUE SPARK TECHNOLOGIES, INC.

Wireless patient thermometer, single-use
Primary Device ID00851203006012
NIH Device Record Keycb69d621-4c55-46a9-a5b8-04fd956b0c5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempTraq
Version Model NumberTT-100
Catalog Number601
Company DUNS603031365
Company NameBLUE SPARK TECHNOLOGIES, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com
Phone14402495440
Emailinfo@temptraq.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851203006012 [Primary]

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 Date2019-04-29
Device Publish Date2016-08-26

On-Brand Devices [TempTraq]

00851203006043TempTraq Consumer iOS App
00851203006036TempTraq Consumer Android App
00851203006029Continuous Temperature Monitor
00851203006012Continuous Temperature Monitor
00851203006005Continuous Temperature Monitor

Trademark Results [TempTraq]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TEMPTRAQ
TEMPTRAQ
98719446 not registered Live/Pending
Blue Spark Technologies, Inc.
2024-08-27
TEMPTRAQ
TEMPTRAQ
86261189 4766108 Live/Registered
Blue Spark Technologies, Inc.
2014-04-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.