FDA.report

TempTraq®

Primary DI
00851203006197
Brand
TempTraq®
Company
BLUE SPARK TECHNOLOGIES, INC.
Model
TT-300
Catalog number
619
Published
2020-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K143267000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K143267000TempTraq TT-100Blue Spark Technologies, Inc.2015-09-02FLL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00851203006197PrimaryGS10
00851203006104Unit of UseGS10

GMDN Terms

TermDefinition
Wireless patient thermometer, single-useA battery-powered electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for data display, recording and analysis. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit), and is typically used to monitor a fever during daily activities and sleep. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
14402495441info@temptraq.com

Regulatory Flags

DUNS number
603031365
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00851203006449TempTraq®4.x.x2026-02-26
00851203006470TempTraq®TT-1006472026-02-26
00851203006487TempTraq®TT-3006482026-02-26
00851203006432TempTraq®4.x.x2025-03-05
00851203006364TempTraq®4.x.x2025-02-25
00851203006371TempTraq®4.x.x2025-02-25
00851203006388TempTraq®4.x.x2025-02-25
00851203006050TempTraq®TT-1006212020-10-21
00851203006104Cell Therapy 360 Wearable Tech V1TT-3006222020-10-21
00851203006234Cell Therapy 360 Wearable Tech V12.6.0.10813 CV2020-10-21
00851203006241Cell Therapy 360 Wearable Tech V12.6.1 (1106) CV2020-10-21
00851203006258Cell Therapy 360 Wearable Tech V12.6.0 (1099) R2020-10-21
00851203006265Cell Therapy 360 Wearable Tech V12.6.0.10768 PC2020-10-21
00851203006272Cell Therapy 360 Wearable Tech V12.3.0.10160 CV2020-10-21
00851203006173TempTraq®TempTraq Clinician Web App2019-04-29
00851203006036TempTraqTempTraq Consumer Android App2016-08-26
00851203006043TempTraqTempTraq Consumer iOS App2016-08-26
00851203006111TempTraq®TempTraq Patient Android App2018-02-15
00851203006128TempTraq®TempTraq Clinician Android App2018-02-15
00851203006135TempTraq®TempTraq Patient iOS App2018-03-22

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